Abdominal Aortic Aneurysms: Systems And Methods Of Use

ABSTRACT

A method of releasing a bare stent of a stent graft includes moving a lumen, to which a proximal apex capture portion of an apex capture device is fixed, the proximal apex capture portion defining a radial restraint, along a major axis between a first position, in which tines of the proximal apex capture portion are mated with slots of a distal apex capture portion and overlie bosses extending radially from a major axis of the apex capture device, and a second position, in which the tines are not mated with the slots and do not overlie the bosses, to thereby release apices of a bare stent from a space defined by the tines, the bosses and the distal apex capture portion.

RELATED APPLICATIONS

This application is a divisional of Ser. No. 15/166,818 filed on May 27,2016, which is a divisional of U.S. application Ser. No. 12/459,387,filed on Jun. 30, 2009, now U.S. Pat. No. 9,364,314, issued Jun. 14,2016, which claims the benefit of U.S. Provisional Application No.61/077,031, filed on Jun. 30, 2008, and U.S. Provisional Application No.61/164,545, filed on Mar. 30, 2009. The entire teachings of the aboveapplications are incorporated herein by reference.

BACKGROUND OF THE INVENTION

Stent graft delivery systems have been designed to treat abdominalaortic aneurysm (AAA) to minimize the diameter or “French” size of theportion to be inserted into the patient. This usually results in severecompression of very large stents into small diameter tubes or catheters.The drastic inward compression results in high longitudinal forces forloading the stent graft—pushing the pre-compressed stent into thedelivery system sheath—and in high deployment forces—occurring when thestent graft is unsheathed at the time of clinical deployment. Otherfactors cumulatively add to this deployment force including, forexample, friction between components of the delivery system handle andthe amount of tortuosity in which the sheath is navigated through thepatient's vessels.

Deployment accuracy is a term referring to the ability of a physician tochoose a target site for stent graft placement within the patient andthe ability to “accurately” deliver the stent at the implantation site,the accuracy being measured with respect to both the longitudinal androtational position of the stent graft. High deployment forces reduce aphysician's ability to control deployment accuracy. Other factors canadversely affect deployment accuracy and present additional problemsthat the physician must address or for which the physician mustcompensate. These include quality of viewing equipment (fluoroscopy) andrapid blood flow. It would be desirable, therefore, to provide a systemthat increases stent graft deployment accuracy.

“Pin-and-pull” is a term that has been used in the art to describe manyearly types of stent/stent graft delivery systems. In pin-and-pullsystems, there are two main components: an inner support catheter (e.g.,a tube or a rod); and an outer sheath. The outer sheath longitudinallyslides over the inner support catheter and can be freely rotated aroundthe inner support catheter (i.e., rotation is independent oflongitudinal outer sheath motion). To load a stent graft therein, theinner support catheter is drawn proximally (towards user) so that aninterior chamber is created at the distal end of the outer sheath. Thestent graft is compressed radially and inserted into this chamber sothat the outer sheath houses the compressed stent graft inside itsdistal end. In this configuration, the inner support catheter preventsthe stent graft from moving in a direction towards the physician(proximally) when the outer sheath is retracted. Deployment of the stentgraft occurs naturally when the outer sheath is retracted because theindividual stents of the stent graft have an outward bias towards theirrespective fully expanded state.

When the physician is using a pin-and-pull device, the stent graft ismaneuvered to the deployment site using fluoroscopy, for example. Atthis point, the physician is prepared to release the stent graft. Thestent graft is deployed in the vessel by “pinning” the inner supportcatheter relative to the patient and “pulling” back on the outersheath—thus deriving from these actions the “pin-and-pull” nomenclature.

Because the outer sheath is compressing the stent graft, movement of theouter sheath towards the physician tends to draw the stent graft in thisdirection. Thus, without the inner support catheter, the stent graftwill not be deployed. Minimizing the deployment force allows the sheathto retract with greater ease. It is, therefore, desirable to have thesheath retract as easily as possible.

With high deployment forces, the physician has less control over theplacement accuracy. The highest deployment force occurs when the sheathfirst begins to retract. Once the user has overcome the initial frictionbetween the sheath and the compressed stent, the force then needed fordeployment plummets. This rapid decline is almost instantaneous and,often, the physician is not able to react quickly enough to lower theforce being supplied to the delivery system. This failure to reactresults in deployment of more of the stent graft than intended by thephysician or in a deployment that fails to hit the intended target site(i.e., low deployment accuracy).

Some mechanisms have been employed to add control to stent graftdeployment and minimize this rapid release of stored energy within thedelivery system. These mechanisms include screw-type retraction of thestent sheath and/or incorporation of “stops” which prevent inadvertentrelease of the stent. The screw-type mechanisms slow down the release ofthe stored energy and help maintain better control of stent release.These screw-type mechanisms also can impart a mechanical advantage byconverting the linear force to a torque force. Stop-type mechanisms donot affect conversion or lowering of the deployment force, but help bypreventing any over-compensation of the force and any instantaneousrelease of the force. Neither of these, however, significantly increasedeployment accuracy and an improvement in performance would bedesirable.

Modular disassociation creates serious type III endoleaks, which canhave significant clinical consequences. Creating a mechanicalinteraction, the modular pull out force will exceed clinicalrequirements. This type of securement significantly reduces thelikelihood of this event. Also, this system does not require rotationalalignment between the receiving and inserting components. This makes themechanism substantially invisible to the doctor and does not add anycomplexity to the procedure. Further, the system prevents adversecomplications during the procedure. By using a proximally facing fold inthe graft, there is virtually no chance of accidental ensnarement of aguide wire during the procedure. (If loops or holes were placed in thefirst member, then a guidewire could potentially get caught without thephysician being aware of that ensnarement.) Moreover, the folds in thegraft create extra layers of material. Thus, if a securing componentwere to wear through some of the graft, there multiple layers of thegraft will remain to prevent an endoleak. This includes the layer ofgraft on the inserting member. It is unlikely that wearing of the graftto create an endoleak would occur in both the catheter and catheterdirection through three to four layers of material. Significantly, byhaving multiple engaging members of the second (inserting) stent graft,there is redundancy in the vessel repair system. Therefore, even if somemembers miss the pockets or even if some members fracture, the overallintegrity of the system will still be intact. Further redundancy in thevessel repair system is present by providing multiple sets of folds inthe first component. These folds can be at the very end of the stentgraft as well as multiple folds moving up the length of the stent graft.This configuration and variants thereof can cover any leg prosthesisstent graft.

Thus, there is a need to develop new, useful and effective deliverysystems, components and methods to treat AAA.

SUMMARY OF THE INVENTION

The present invention relates to delivery systems, components ofdelivery systems and methods of using the delivery systems and itscomponents to treat vascular damage, in particular AAA.

In an embodiment, the invention is an apex capture device, comprising aproximal apex capture portion that includes a nose, wherein the nosedefines at least one radial restraint that is substantially parallel toa major axis of the proximal capture portion, and a plurality of tinesextending distally from the nose, the tines radially distributed aboutthe major axis radial to a most proximal radial restraint andsubstantially parallel to the major axis; a distal apex capture portiondefining slots distributed radially about the major axis, the slotsmateable with the tines by relative movement of the proximal and distalapex capture portions along the major axis; a plurality of bossesextending radially from the major axis between the nose and the distalapex capture portion and aligned with the slots along the major axis innon-interfering relation with movement of the tines into mating relationwith the slots; an elongate member to which the distal apex captureportion is fixed, the elongate member extending through the proximalapex capture portion and the plurality of bosses; and a catheter towhich the proximal apex capture portion is fixed, through which theelongate member extends, whereby movement of the catheter causesmovement of the proximal apex capture portion along the major axisbetween a first position, in which the tines are mated with the slotsand overlie the bosses, and a second position, in which the tines arenot mated with the slots and do not overlie the bosses.

In another embodiment, the invention is a method of releasing a barestent of a stent graft, comprising the steps of moving a catheter towhich a proximal apex capture portion of an apex capture device isfixed, the proximal apex capture portion defining a radial restraint,along a major axis between a first position, in which tines of theproximal apex capture portion are mated with slots of a distal apexcapture portion and overlie bosses extending radially from a major axisof the apex capture device, and a second position, in which the tinesare not mated with the slots and do not overlie the bosses, therebyreleasing apices of a bare stent from a space defined by the tines, thebosses and the distal apex capture portion.

In a further embodiment, the invention is an apex capture deviceassembly, comprising a proximal apex capture portion that includes anose, wherein the nose defines at least one radial restraint that issubstantially parallel to a major axis of the proximal capture portion,and a plurality of tines extending distally from the nose, the tinesradially distributed about the major axis radial to a most proximalradial restraint and substantially parallel to the major axis; a distalapex capture portion defining slots distributed radially about the majoraxis, the slots mateable with the tines by relative movement of theproximal and distal apex capture portions along the major axis; aplurality of bosses extending radially from the major axis between thenose and the distal apex capture portion and aligned with the slotsalong the major axis in non-interfering relation with movement of thetimes into mating relation with the slots; an elongate member to whichthe distal apex capture portion is fixed, the elongate member extendingthrough the proximal apex capture portion and the plurality of bosses; acatheter to which the proximal apex capture portion is fixed, throughwhich the elongate member extends, whereby movement of the cathetercauses movement of the proximal apex portion along the major axisbetween a first position, in which the tines are mated with the slotsand overlie the bosses, and a second position, in which the tines arenot mated with the slots and do not overlie the bosses; a bare stentthat includes struts linked by apices, the struts extending between thetines, a portion of the apices extending between the bosses and thedistal apex capture portion when the times are mated to the slots; andat least one suprarenal barb extending from the stent into the radialrestraint.

In yet another embodiment, the invention is a stent graft system,comprising a luminal graft component; a bare stent component including aplurality of struts joined by proximal and distal apices connecting thestruts, the bare stent component fixed to a proximal end of the luminalgraft component and extending proximally from the proximal end; aninfrarenal stent component proximate to the bare stent component,wherein the infrarenal stent component is distal to the bare stentcomponent and spans a circumferential line defined by apices of the barestent component fixed to the luminal graft component; at least onesuprarenal barb extending distally from at least one suprarenal portionof the bare stent component; and at least one infrarenal barb extendingdistally from at least one infrarenal portion of the bare stent.

In another embodiment, the invention is a stent graft delivery system,comprising a handle that includes a distal grip, and a handle bodyextending from one end of the distal grip, the handle defining a conduitand a track along a portion of the length of the distal grip and thehandle body; an internal lead screw assembly within the track, theinternal lead screw assembly being moveable along a major axis of theconduit, and including a threaded portion that extends through thetrack; a lead screw nut that extends about the handle body andthreadably engaged with the threaded portion of the internal lead screwassembly, whereby rotation of the lead screw nut while abutting thedistal grip causes movement of the internal lead screw assembly relativeto the handle and wherein the lead screw nut simultaneously is slidablealong the handle body while engaged with the internal lead screwassembly, thereby providing at least two mechanisms for causing movementof the internal lead screw assembly relative to the handle.

An additional embodiment of the invention is a slider for a stent graftdelivery system, the slider comprising a slider body defining a centralorifice through which a support member extends and a flush valve orificeextending substantially normal to the central orifice, the slider bodybeing detachably fixable to an internal lead screw assembly; a slidercap coupled to a proximal end of the slider body, the slider capdefining a central orifice that is substantially aligned with thecentral orifice of the slider body and through which the support memberextends; a sheath extending from a distal end of the slider cap, thesheath defining a catheter that is substantially aligned with thecentral opening of the slider body and through which the support memberextends and a valve at the central orifice that provides hemostasis tothe sheath. Optionally, the slide can include a wiper valve at thecentral opening of the slider body proximal to the flush valve orifice,the wiper valve forming a seal about the support member; an x-valve atthe central opening of the slider body proximal to the wiper valve, thex-valve forming a seal about a catheter upon withdrawal of the supportmember from the slider body; and a sheath valve at the central openingof the slider body and proximal to the x-valve, the sheath valve beingoperable by activation of the slider cap to seal the central opening.

In yet another embodiment, the invention is a stent graft system,comprising a first stent graft that includes a first luminal graftcomponent, a plurality of outside stents extending along and fixed to anoutside surface of the first luminal graft component, and an insidestent between two outside stents, one of which is at a distal end of thefirst luminal graft component, the inside stent fixed to an insidesurface of the first luminal graft component, and having a plurality ofbarbs pointed generally proximally within the first luminal graftcomponent; and a second stent graft that includes a second luminal graftcomponent and a plurality of outside stents extending along and fixed toan outside surface of the first luminal graft component, wherebyinsertion of the second stent graft into the distal end of the firstluminal graft component to overlap at least two stents of each of thefirst and second stent grafts will cause interfering relation between atleast a portion of the barbs with a stent or the second luminal graftcomponent of the second stent graft.

Another embodiment of the invention is a stent graft system, comprisinga luminal graft component; a bare stent extending from a proximal end ofthe luminal graft component; at least one proximal barb extendingdistally from a proximal end of the bare stent; and at least one distalbarb extending distally from a distal end of the bare stent, thedistance between the proximal and distal barbs along a major axis of theluminal graft component being in a range of between about 6 mm and about40 mm.

An additional embodiment of the invention is a leg clasp, comprising abarrel; a spool extending from the barrel along a major axis of thebarrel; and a rim at an end of the spool, the rim having a diametergreater than that of the spool but less than that of the barrel.

In yet another embodiment, the invention is a stent graft deliverysystem, comprising a leg clasp that includes a barrel, a spool extendingfrom the barrel along a major axis of the barrel, and a rim at an end ofthe spool, the rim having a diameter greater than that of the spool butless than that of the barrel; a support tube fixed to the barrel andextending from the barrel in a direction opposite that of the spool; anda sheath having an internal diameter greater than that of the barrel andslideably moveable between a first position that covers the spool andrim and a second position that exposes the spool and rim.

A further embodiment of the invention is a stent graft system,comprising a luminal graft component; a bare stent of angled strutsjoined by proximal and distal apices, and extending from a proximal endof the luminal graft component; a proximal stent adjacent the bare stentand within the luminal graft, the proximal stent including angled strutsjoined by apices; and at least one barb extending distally from a distalapex and through the luminal graft component.

In still another embodiment, the invention is a telescoping stent graftsystem, comprising a bifurcated first stent graft that includes abifurcated first luminal graft component, a plurality of stentsextending along and fixed to a surface of one of two legs of thebifurcated first luminal graft component; a second stent graft thatincludes a second luminal graft component and a plurality of stentsextending along and fixed to a surface of the first luminal graftcomponent, whereby the second stent graft can be inserted into thedistal end of a first of two leg components of the bifurcated firstluminal graft component to overlap at least two stents of each of thefirst and second stent grafts; a plurality of stents extending along andfixed to a surface of a second leg of the bifurcated first luminal stentgraft, wherein the first leg is shorter than the second leg, and whereinthe first leg includes at least one more stent than is required foroverlap of at least two stents of the second stent graft.

In yet another embodiment, the invention is a method for treating anabdominal aortic aneurysm, comprising steps of directing a sheath anddistal tip of a delivery system to an abdominal aortic aneurysm of apatient through an artery of the patient, the sheath containing abifurcated stent graft; rotating a lead screw nut of the delivery systemthat is threadably linked to the sheath to thereby retract the sheath atleast partially from the bifurcated stent graft; and sliding the leadscrew nut along a handle body of the delivery device while the leadscrew nut is threadably linked to the sheath to thereby further retractthe sheath, whereby the bifurcated stent graft is at least partiallydeployed in the abdominal aortic aneurysm, thereby treating theabdominal aortic aneurysm.

In still another embodiment, the invention is a stent graft deliverydevice, comprising, an apex capture device assembly that includes aproximal apex capture portion that includes a nose, wherein the nosedefines at least one radial restraint that is substantially parallel toa major axis of the proximal capture portion and a plurality of tinesextending distally from the nose, the tines radially distributed aboutthe major axis radial to a most proximal radial restraint andsubstantially parallel to the major axis, a distal apex capture portiondefining slots distributed radially about the major axis, the slotsmateable with the times by relative movement of the proximal and distalapex capture portions along the major axis, a plurality of bossesextending radially from the major axis between the nose and the distalapex capture portion and aligned with the slots along the major axis innon-interfering relation with movement of the tines into mating relationwith the slots, an elongate member to which the distal apex captureportion is fixed, the elongate member extending through the proximalapex capture portion and the plurality of bosses, a catheter to whichthe proximal apex capture portion is fixed, through which the elongatemember extends, whereby movement of the catheter causes movement of theproximal apex portion along the major axis between a first position, inwhich the tines are mated with the slots and overlie the bosses, and asecond position, in which the tines are not mated with the slots and donot overlie the bosses, a bare stent that includes struts linked byapices, the struts extending between the tines, a portion of the apicesextending between the bosses and the distal apex capture portion whenthe tines are mated to the slots and at least one suprarenal barbextending from the stent into the radial restraint; and a leg claspthrough which the elongate member and catheter extend, the leg claspincluding, a barrel, a spool extending from the barrel along a majoraxis of the barrel, and a rim at an end of the spool, the rim having adiameter greater than that of the spool but less than that of thebarrel.

An additional embodiment of the invention is an x-valve assembly,comprising an x-valve and a gasket supporting the x-valve.

The delivery systems, components of delivery systems and methods of theinvention can be employed to treat aortic aneurysms, such as abdominalaortic aneurysms. Advantages of the claimed delivery systems, componentsof delivery devices and methods of the invention include, for example,the following.

Benefits achieved by the invention are represented, for example, byFIGS. 1 to 15, specifically FIGS. 15A, 15B, and 15C. Currentpin-and-pull systems have an undesired force to the inner stabilizingmember during deployment because there is a tendency to flex wheregripped thereon (see FIGS. 15A and 15B). This flexing causedmisalignment of the sheath hub and the inner stabilizing member, which,in turn, required the physician to increase deployment forces forretracting the outer sheath, thus, correspondingly increasing the forceagainst the inner stabilizing member (a damaging cycle). The telescopicsystems of the invention, in contrast, offer protection of the innerstabilizing member because the force is not directly applied to theinner stabilizing member. The two-rigid-tube telescopic system of theinvention incorporates two hard surfaces that retract on one anotherover the inner stabilizing member and, thereby, reduce any chance ofbuckling of the inner stabilizing member. During the retraction process,the force is transmitted uniformly over the inner stabilizing member.

By creating a mechanical interaction, the modular pull out force canexceed clinical requirements. Modular disassociation creates serioustype III endoleaks, which can have significant clinical consequences.This type of securement significantly reduces the likelihood of thisevent. Also, this system does not require rotational alignment betweenthe receiving and inserting components. This makes the mechanismsubstantially invisible to the doctor and does not add any complexity tothe procedure. Further, the system prevents adverse complications duringthe procedure. By using a proximally facing fold in the graft, there isvirtually no chance of accidental ensnarement of a guide wire during theprocedure. If loops or holes were placed in the first member, then aguidewire could potentially get caught without the physician being awareof that ensnarement.

Moreover, the folds in the graft create extra layers of material.Therefore, even if a securing component were to wear through some of thegraft, there still will be multiple layers of the graft left to preventan endoleak. This includes the layer of graft on the inserting member.It is very unlikely that wearing of the graft to create an endoleakwould occur in both the catheter and albumen direction through three tofour layers of material. Significantly, by having multiple engagingmembers of the second (inserting) stent graft, there is redundancy inthe vessel repair system. Therefore, even if some members miss thepockets or even if some members fracture, the overall integrity of thesystem will still be intact. Further redundancy in the vessel repairsystem is present by providing multiple sets of folds in the firstcomponent. These folds can be at the very end of the stent graft as wellas multiple folds moving up the length of the stent graft. Thisconfiguration and variants thereof can cover any leg prosthesis stentgraft.

In addition, barbs located at suprarenal and infrarenal positions, mayprovide positive fixation and the leg clasp of the invention may providefor accurate control of the graft systems during cannulation andplacement of the graft system in the vasculature.

Thus, the delivery systems, components of delivery systems and methodsof the invention can be used to treat AAA and, therefore, avoidcomplications and death consequent to life threatening vascularconditions.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 represents an embodiment of a delivery system of the invention.

FIG. 2 represents an embodiment of a delivery system of the invention.

FIG. 3 represents an embodiment of a delivery system of the invention.

FIG. 4 depicts an embodiment of a stent delivery system of theinvention.

FIG. 5 depicts an embodiment of a stent delivery system of theinvention.

FIG. 6 depicts an embodiment of a stent delivery system of theinvention.

FIG. 7 is an alternative embodiment of the delivery system of theinvention.

FIG. 8 is an alternative embodiment of the delivery system of theinvention.

FIG. 9 is an alternative embodiment of the delivery system of theinvention.

FIG. 10 is an embodiment for connecting an outer sheath handle to aninner screw that can be employed in the delivery systems of theinvention. Screws (716) are offset to fall in the threads.

FIG. 11 is an embodiment for connecting an outer sheath handle to aninner screw that can be employed in the delivery systems of theinvention.

FIG. 12 is an embodiment of the delivery system of the invention. Thehandle is turned (curved arrow) to retract sheath. The handle is heldstationary while turning the handle to retract the sheath.

FIG. 13 is an embodiment of the delivery system of the invention. Whenthreads are completely disengaged, the handle will lock into the slotsand the bore spring and sealing spring will be exposed.

FIG. 14 is an embodiment of the delivery system of the invention. Thesheath is retracted so the main body of the bifurcated graft is exposedby sliding the handle over the threaded engagement.

FIGS. 15A, 15B, 15C and 15D are embodiments of the delivery system ofthe invention. As shown in FIG. 15A, the apex clasp is released todeliver the bifurcated stent graft. The arrow depicts force.

FIG. 16 is another embodiment of the delivery system of the invention.

FIG. 17 is another embodiment of the delivery system of the invention.

FIG. 18 is another embodiment of the delivery system of the invention.

FIG. 19 is another embodiment of the delivery system of the invention.

FIG. 20 is another embodiment of the delivery system of the invention.The handle is turned (curved arrow) to retract the sheath. The handle iskept stationary while turning to retract the sheath.

FIG. 21 is another embodiment of the delivery system of the invention.Once the threads are completely disengaged the bare spring and sealingspring will be exposed and the turning of the handle will not retractthe sheath back any further.

FIG. 22 is another embodiment of the delivery system of the invention.Pin and pull—retract the sheath so the main body of the graft is exposedby sliding the handle back over the lead screw handle.

FIG. 23 is another embodiment of the delivery system of the invention.The apex clasp is released.

FIG. 24 is another embodiment of the delivery system of the invention.

FIG. 25 is another embodiment of the delivery system of the invention.

FIG. 26 is another embodiment of the delivery system of the invention.

FIG. 27 is another embodiment of the delivery system of the invention.

FIG. 28 is another embodiment of the delivery system of the invention.

FIG. 29 is another embodiment of the delivery system of the invention.Arrow indicates a distal end of an inner support member.

FIG. 30 is another embodiment of the delivery system of the invention.Arrow indicates proximal end of an inner support member.

FIG. 31 is another embodiment of the delivery system of the invention.Arrow indicates component to attach internal tube to distal handle grip.

FIG. 32 is another embodiment of the delivery system of the invention.Arrow indicates stop position indicator in locked position.

FIG. 33 is a further embodiment of the delivery system of the invention.

FIG. 34 is a further embodiment of the delivery system of the invention.Arrow indicates a side view of a lead screw.

FIG. 35 is a further embodiment of the delivery system of the invention.Arrow indicates an end view of a lead screw.

FIG. 36 is a further embodiment of the delivery system of the invention.Arrow indicates a lead screw rail.

FIG. 37 is a further embodiment of the delivery system of the invention.

FIG. 38 is a further embodiment of the delivery system of the invention.

FIG. 39 is a further embodiment of the delivery system of the invention.

FIG. 40 is a further embodiment of the delivery system of the inventionthat includes a distal clasp assembly (ASSY) and a loading mandrel(manufacture (MFG) aid).

FIG. 41 is a further embodiment of the delivery system of the invention.

FIG. 42 is a further embodiment of the delivery system of the invention.

FIG. 43 is a further embodiment of the delivery system of the invention.

FIG. 44 is a further embodiment of the delivery system of the invention.

FIG. 45 is a further embodiment of the delivery system of the invention.

FIG. 46 is a further embodiment of the delivery system of the invention.

FIG. 47 is a further embodiment of the delivery system of the invention.

FIG. 48 is a further embodiment of the delivery system of the invention.

FIG. 49 is a further embodiment of the delivery system of the invention.

FIG. 50 is a further embodiment of the delivery system of the invention.

FIG. 51 is a further embodiment of the delivery system of the invention.

FIG. 52 is a lead screw embodiment of the invention.

FIG. 53 is a lead screw embodiment of the invention.

FIG. 54 is a lead screw embodiment of the invention.

FIGS. 55A and 55B is another embodiment of the delivery system of theinvention.

FIG. 56 is another embodiment of the delivery system of the invention.

FIGS. 57A, 57B, 57C, 57D, 57E and 57F are another embodiment of thedelivery system of the invention (sheath valve assembly).

FIG. 58 is an embodiment of a distal tip of the delivery system of theinvention.

FIG. 59 is an embodiment of a distal tip of the delivery system of theinvention.

FIG. 60 is an embodiment of a distal tip of the delivery system of theinvention.

FIG. 61 is an embodiment of a delivery system of the invention.

FIG. 62 is an embodiment of a delivery system of the invention.

FIG. 63 is an embodiment of a delivery system of the invention.

FIGS. 64A and 64B are embodiments of a delivery system of the invention.

FIG. 65 is an additional embodiment of the delivery system of theinvention. An exemplary length of the sheath can be 84 cm.

FIG. 66 is an additional embodiment of the delivery system of theinvention that includes a tip assembly (ASSY), support member assembly(ASSY) and a guidewire (GW) hypo-tube.

FIG. 67 is an additional embodiment of the delivery system of theinvention that employs, for example, stainless steel and nylon.

FIG. 68 is an additional embodiment of the delivery system of theinvention.

FIG. 69 is an additional embodiment of the delivery system of theinvention.

FIGS. 70A, 70B and 70C are embodiments of a leg clasp system of theinvention.

FIG. 71 is a representation of an abdominal aortic aneurysm.

FIGS. 72A, 72B and 72C are embodiments of a stent graft system of theinvention. FIG. 72A is an example of placement of a stent graft systemof the invention to treat an abdominal aortic aneurysm.

FIG. 73 is an embodiment of a stent of the invention.

FIG. 74 is an embodiment of a stent of the invention.

FIG. 75 is an embodiment of a stent of the invention.

FIGS. 76A and 76B are embodiments of a component of a delivery system ofthe invention.

FIG. 77 is an embodiment of an eyelet of a stent of the invention.

FIGS. 78A, 78B and 78C are embodiments of a telescoping stent graftssystem of the invention.

FIGS. 79A, 79B and 79C are embodiments of a telescoping stent graftssystem of the invention.

FIG. 80 is an embodiment of a stent of the invention.

FIG. 81 is a representation of an unexpanded stent of the invention.

FIG. 82 is a representation of an unexpanded stent of the invention.

FIG. 83 is a representation of an unexpanded stent of the invention.

FIG. 84 is a representation of an unexpanded stent of the invention.

FIG. 85 is a representation of an unexpanded stent of the invention.

FIGS. 86A, 86B, 86C, 86D and 86E are an embodiment of the apex capturedevice of the invention.

FIGS. 87A and 87B are embodiments of the apex capture device of theinvention.

FIGS. 88A and 88B are embodiments of the apex capture device of theinvention.

FIG. 89 is an embodiment of multiple stents of the invention.

FIG. 90 is an embodiment of multiple stents of the invention.

FIG. 91 is an embodiment of multiple stents of the invention.

FIG. 92 is an embodiment of multiple stents of the invention.

FIG. 93 is an embodiment of multiple stents of the invention.

FIG. 94 is an embodiment of multiple stents of the invention.

FIG. 95 is a representation of a modular component of a stent-graftsystem of the invention.

FIG. 96 is a representation of a modular component of a stent-graftsystem of the invention.

FIG. 97 is an embodiment of a stented graft of the invention.

FIG. 98 is an embodiment of a stented graft of the invention.

FIG. 99 is an embodiment of a stented graft of the invention.

FIG. 100 is an embodiment of a stented graft of the invention.

FIG. 101 is an embodiment of a stented graft of the invention.

FIG. 102 is an embodiment of a stented graft of the invention.

FIG. 103 is an embodiment of a stent of the invention.

FIG. 104 is an embodiment of a stent of the invention.

FIGS. 105A, 105B and 105C are embodiments of a stent of the invention.

FIG. 106 is an embodiment of a stent of the invention.

FIG. 107 is an embodiment of a barb of the invention.

FIG. 108 is an embodiment of a stent of the invention.

FIG. 109 is an embodiment of a stent graft of the invention.

FIG. 110 is an embodiment of a barb of the invention.

FIG. 111 is an embodiment of a barb of the invention.

FIG. 112 is an embodiment of a stent graft of the invention.

FIG. 113 is an embodiment of a stent graft of the invention.

FIG. 114 is a further embodiment of a component of the delivery systemof the invention.

FIG. 115 is a further embodiment of a component of the delivery systemof the invention.

FIG. 116 is a representation of a stent graft system of the invention asviewed following placement in a mock-silicon aorta.

FIG. 117 is an embodiment of a component of the delivery system of theinvention.

FIG. 118 is an embodiment of a component of the delivery system of theinvention.

FIG. 119 is an embodiment of a component of the delivery system of theinvention.

FIG. 120 is an embodiment of a component of the delivery system of theinvention.

FIG. 121 is an embodiment of a component of the delivery system of theinvention.

FIG. 122 is an embodiment of a component of the delivery system of theinvention.

FIG. 123 is an embodiment of a component of the delivery system of theinvention.

FIG. 124 is an embodiment of a component of the delivery system of theinvention.

FIG. 125 is representative of a leg clasp of the invention.

FIG. 126 is representative of a leg clasp of the invention.

FIGS. 127A, 127B, 127C and 127D are representative of a telescopingstent graft system of the invention.

FIG. 128 is an embodiment of the delivery system of the invention.

DETAILED DESCRIPTION OF THE INVENTION

The features and other details of the invention, either as steps of theinvention or as combinations of parts of the invention, will now be moreparticularly described and pointed out in the claims. It will beunderstood that the particular embodiments of the invention are shown byway of illustration and not as limitations of the invention. Theprinciple features of this invention can be employed in variousembodiments without departing from the scope of the invention.

In an embodiment, represented by FIGS. 1 through 57 as an example, theinvention is a stent graft delivery system 5500, comprising a handlethat includes distal grip 5530 and handle body 5540 extending from oneend of distal grip 5530, the handle defining conduit and track 5542along a portion of the length of distal grip 5530 and handle body 5540;an internal lead screw assembly 5510 within the conduit, the internallead screw assembly 5510 being moveable along a major axis of theconduit, and including a threaded portion 5512 that extends through thetrack 5542; a lead screw nut 5520 that extends about the handle body5540 and threadably engaged with the threaded portion 5512 of theinternal lead screw assembly 5510, whereby rotation of the lead screwnut 5520 while abutting the distal grip 5530 causes movement of theinternal lead screw assembly 5510 relative to the handle and wherein thelead screw nut 5520 simultaneously is slidable along the handle body5540 while engaged with the internal lead screw assembly 5510, therebyproviding at least two mechanisms for causing movement of the internallead screw assembly 5510 relative to the handle.

Referring to FIG. 57A, the stent graft delivery system can furtherinclude a support member 5740 fixed to the handle body, and an outersheath 5550 extending about a portion of the support member 5740 andfixed, either directly or through slider 5700, to the internal leadscrew assembly 5510, whereby relative movement of the handle body 5540and the internal lead screw assembly 5510 causes relative movement ofthe support member 5740 and the outer sheath 5550.

The internal lead screw assembly 5510 of the stent graft delivery system5500 of the invention can define an opening essentially coaxial with thehandle, wherein the support member extends through the internal leadscrew assembly, as shown in FIG. 55A.

As can be seen in the inset of FIG. 57A, support member 5740 includes ahypo-tube 5742 and a support tube 5744 within the hypo-tube 5742.Hypo-tube 5742 typically is formed of stainless steel, while supporttube 5744 typically is formed of nylon, such as VESTAMID®. Hypo-tube5742 is fixed to the handle body, such as at proximal end cap 5544, asshown in FIG. 56 (also shown as proximal end cap 3350 in FIG. 33). Alsoshown in the inset to FIG. 57A, but not part of support member 5740, areelongate member 8614, which is connected to distal apex capture portion8610, and catheter 8613, which is connected to proximal apex captureportion 8600 a, all of which are shown in FIG. 86D.

The stent graft delivery system of the invention can further include aslider 5700. The slider 5700 of the stent graft delivery systemcomprises a slider body 5720 defining a central orifice through whichthe support member 5740 extends and a flush valve orifice 5712 extendingsubstantially normal to the central orifice, the slider body 5720 beingdetachably fixable to the internal lead screw assembly 5510 (FIG. 55A bysuitable means, such as, for example, release pin 6210, which extendsthrough internal lead screw assembly into slider, as shown in FIGS. 62and 63); a slider cap 5710 coupled to a distal end of the slider body5720, the slider cap 5710 defining a central orifice that issubstantially aligned with the central orifice of the slider body 5720and through which the support member 5740 extends; a sheath valve knob5790 threadably coupled to slider body 5720, an outer sheath 5550extending from a distal end of the slider cap 5710, the outer sheath5550 defining a catheter that is substantially aligned with the centralopening of the slider body 5720 and through which the support member5740 extends; a wiper valve 5750 at the central opening of the sliderbody proximal to the flush valve orifice 5712, the wiper valve 5750forming a seal about the support member; an x-valve assembly 5760 at thecentral opening of the slider body proximal to the wiper valve 5750, thex-valve assembly 5760 forming a seal about a guidewire within supporttube 5744 upon withdrawal of the support member from the slider body5720; and a sheath valve 5770 at the central opening of the slider body5720 and proximal to the x-valve assembly 5760, the sheath valve 5770being operable by activation of sheath valve knob 5790 to seal thecentral opening.

In an embodiment, the x-valve assembly 5760 includes a nitinol gasket asshown in FIGS. 57B through 57F.

“Proximal” means, when reference is made to a delivery system or acomponent of a delivery system, such as an apex capture device, a sliderfor a stent graft delivery system or a leg clasp, closest to theclinician using device. Likewise, “distal” means, when reference is madeto a delivery system or a component of a delivery system, such as anapex capture device, a slider for a stent graft delivery system or a legclasp, away from the clinician using the device.

When reference is made to a “stent” or a “stent graft system,”“proximal” means that end of the stent or stent graft system that istowards the head of the patient and “distal” means that end of the stentor stent graft system that is away from the head of the patient.

In another embodiment, the invention is a slider 5700 for a stent graftdelivery system, the slider 5700 comprising a slider body 5720 defininga central orifice through which a support member 5740 extends and aflush valve orifice 5712 extending substantially normal to the centralorifice, the slider body 5720 being detachably fixable to an internallead screw assembly 5510 (FIGS. 55A, 55B and 56); a slider cap 5710(FIG. 57A) coupled to a distal end of the slider body, the slider cap5710 defining a central orifice that is substantially aligned with thecentral orifice of the slider body 5720 and through which the supportmember extends; a sheath valve knob 5790 threadably coupled to sliderbody 5720, an outer sheath 5550 extending from a distal end of theslider cap 5710, the outer sheath 5550 defining a lumen that issubstantially aligned with the central opening of the slider body 5720and through which the support member 5740 extends; a wiper valve 5750 atthe central opening of the slider body 5720 proximal to the flush valveorifice 5712, the wiper valve 5750 forming a seal about the supportmember 5740; an x-valve assembly 5760 at the central opening of theslider body 5720 proximal to the wiper valve 5750, the x-valve assembly5760 forming a seal about a guidewire within support tube 5744 uponwithdrawal of the support member 5740 from the slider body 5720; and asheath valve 5770 at the central opening of the slider body 5720 andproximal to the x-valve assembly 5760, the sheath valve 5770 beingoperable by activation of the sheath valve knob 5790 to seal the centralopening.

FIGS. 61-64B are embodiments of a delivery system of the invention.

Referring now to FIGS. 1 to 3, an exemplary embodiment of an improvedpin-and-pull delivery system 100 according to the present invention isshown. The pin-and-pull delivery system 100 provides an inner catheter110 that is slidably disposed within an outer sheath control catheter120. This configuration of the catheter 110, 120 can also be referred toas a telescopic assembly. The outer sheath control catheter 120 islongitudinally and rotationally fixed to a sheath 130 that is used tohouse the non-illustrated stent graft.

In an exemplary embodiment, the outer sheath control catheter 120 is analuminum tube attached to a sheath hub 140, which is attached to thesheath 130. The inner catheter 110 is polycarbonate tube having alongitudinally cut slot 310 (e.g., see FIG. 3). The inner catheter 110is longitudinally and rotationally fixed to a pushrod 150 (e.g., astainless steel hypo-tube). By attaching the outer sheath controlcatheter 120 to the sheath hub 140, the inner catheter 110 can beretracted into the outer sheath control catheter 120 and will maintainrotational alignment of the catheters 110, 120 by the presence of asetscrew 320 engaged in the slot 310. The groove and set-screwconfiguration will prevent the sheath 130 from rotating when the stentgraft is deployed, which movement undesirably twists the prosthesis froma desired implantation position. This device is beneficial when usedwith a detachable sheath because the hemostasis 160, over the push rod150, is in front of the catheters 110, 120.

FIGS. 4 to 6 illustrate how the delivery system of FIGS. 1 to 3 can beused to implant a bifurcated stent graft. When the compressed bifurcatedstent graft 410 is positioned at a target site, the delivery system ispinned with respect to the patient. The outer sheath control catheter120 is drawn proximally from the position shown in FIG. 4 to theposition shown in FIG. 5. With the outer sheath control catheter 120 inthe fully retracted position (FIG. 5), the stent graft 410 is almostcompletely deployed in the patient's vessel. The only remaining controlof the stent graft 410 is the releasable grasping of bare stent apices412 by the apex capture device 510 of the delivery system. Control ofthe apex capture device 510 occurs from the proximal-most end of thepushrod 150. One exemplary embodiment of the apex capture device 510 andits control assembly is disclosed in the family of applicationsbeginning with U.S. Provisional Patent Application Ser. No. 60,499/652,filed Sep. 3, 2003, and U.S. patent application Ser. No. 10/784,462,filed Feb. 23, 2004, which applications and the entire family thereof ishereby incorporated by reference herein in its entirety. In such anembodiment, a non-illustrated control rod internal to the pushrod 150 ismoved relative (arrow A in FIG. 6) to the pushrod 150 to separate thetines grasping one or more of the exposed bare stent apices 412 fromcontrol surfaces. This movement creates a gap therebetween to free thebare stent apices 412 from their controlled capture.

An alternative embodiment to that illustrated in FIGS. 5 and 6 is shownin FIGS. 7 to 9. This delivery system 700 improves the control andaccuracy of deployment of the stent graft by adding mechanical advantageto the retraction of the introducer outer sheath. Mechanical advantageallows for a “smooth” retraction of the outer sheath by not allowing thebuild up of potential energy, stored in the compressed stent graft, tocause an unexpected jumping or jerking motion during outer sheathretraction. More specifically, the delivery system 700 has twointerconnecting parts: a hollow outer sheath handle 710 and an innerscrew handle 720. The proximal end of the outer sheath handle 710 has aninterior cavity for receiving therein the distal end of the inner screwhandle 720.

One exemplary embodiment for connecting the outer sheath handle 710 tothe inner screw handle 720 is illustrated in FIGS. 10 and 11. A threadengagement portion 712 of the outer sheath handle 710 has two opposingthreaded engagement devices 714, 716 longitudinally offset from oneanother as illustrated in FIG. 10. One of the threaded engagementdevices 714 can be, for example, a ball screw, and the other threadedengagement device 716 can be a set screw. The inner surface of thehollow outer sheath handle 710 is smooth in this particular embodiment.Engagement of the outer sheath handle 710 to the threads 726 of theinner screw handle 720 is made by having the threaded engagement devices714, 716 ride in the threads of the inner screw handle 720. Thus,turning of the inner screw handle 720 causes the outer sheath handle 710to retract over or extend from the distal end of the inner screw handle720 in a controlled fashion. Turning can be assisted with a proximalturn knob 722 rotationally fixed to the inner screw handle 720.

Threads 726 extends for a longitudinal length that is greater than theamount that is necessary to overcome the greatest force required forstent graft deployment. Once that greatest point of force is overcome,the chance of handle jerk or slippage decreases and, therefore, the twohandle portions 710, 720 can be moved longitudinally freely with respectto one another. To achieve the transition from longitudinal controlledand slow movement to longitudinal free movement (and speedy if desired),at the proximal end of the threads of the inner screw handle 720, screwchannels 724 can be cut into the handle body to allow the threadedengagement device 716 to fall into one of the screw channels 724 and thethreaded engagement device 714 to fall into the other channel (notillustrated) on the opposite side of the inner screw handle 720. Athreaded engagement device 714 can be, for example, a ball screw, whichwould be desirable in this configuration because it can be used tocenter the threads against the relatively harder threaded engagementdevice 716, such as a set screw. Changing the force the threadedengagement devices 714, 716 impart against the threads can beaccomplished by adjusting the tension on a ball of the ball set screw orby decreasing the depth of a set screw into the handle 710.

Functioning of the delivery system 700 is illustrated, for example, inthe diagrams of FIGS. 12, 13, 14, 15A, 15B, 15C and 15D. Before theinner screw handle 720 is turned to retract the outer sheath handle 710,the outer sheath catheter 1210 completely covers the stent graft 1220,which is loaded therein just behind (proximal of) the nose cone 1230.The turn knob 722 is rotated to move the outer sheath handle 710proximally and begin to deploy the stent graft 1220 from the outersheath catheter 1210. The user holds the inner screw handle 720longitudinally stationary while turning so that the outer sheathcatheter 1210 moves proximally. This step is shown in FIG. 13. Once thethreads 726 (FIG. 12) are completely disengaged from the threadengagement portion 712 of the outer sheath handle 710, the outer sheathhandle 710 will rotationally lock into the screw channels 724 whilestill being longitudinally free to move with respect to the inner screwhandle 720. At this point, the bare stent 1310 and the first sealingstent 1320 are exposed. After channel lock occurs, the proximal end ofthe stent graft 1220 is exposed from the outer sheath catheter 1210 asshown in FIG. 13. With the opposing threaded engagement devices 714, 716(FIG. 11) locked into the screw channels 724 (FIG. 12), the outer sheathhandle 710 can no longer rotate with respect to the inner screw handle720 and, now, can be moved proximally as desired by the user.Accordingly, the outer sheath catheter 1210 can be retracted so that theentire body of the stent graft 1220 is exposed as shown in FIG. 14. Atthis point, the outer sheath handle 710 is positioned over the innerscrew handle 720 and up to the turn knob 722 and the stent graft 1220 isonly held to the delivery system 700 by the apex clasp device 1410. Withrelease of the apex clasp device 1410, the stent graft 1220 is releasedfrom the delivery system 700 and, thereafter, the delivery system 700can be removed from the patient without impacting the implantation ofthe stent graft 1220.

The delivery system 700 of FIGS. 12, 13, 14, 15A, 15B, 15C and 15D canbe loaded with a 28 mm×150 mm graft into a 19.5 French OD braidedintroducer sheath, for example. In this configuration, the deliverysystem can deploy the bifurcated stent graft 1220 utilizing themechanical advantage applied by the screw mechanism to release the firstsection of the graft (bare stent 1310 and first sealing stent 1320). Theremainder of the stent graft can, then, be deployed by the pin-and-pullassembly of the device after the threads 726 are disengaged. Thisconfiguration eliminates any requirement to have the physician activelydisengage the threads.

Benefits achieved by the telescopic configurations shown in FIGS. 1 to15 are illustrated with regard to FIGS. 15A, 15B, 15C and 15D. Thepin-and-pull systems of the prior art experienced an undesired force tothe inner stabilizing member during deployment because there is atendency to flex where gripped thereon (FIGS. 15A, 15B, 15C and 15D).This flexing caused misalignment of the sheath hub and the innerstabilizing member, which, in turn, required the physician to increasedeployment forces for retracting the outer sheath, thus, correspondinglyincreasing the force against the inner stabilizing member (a damagingcycle).

An alternative to the two-part controlled deployment of FIGS. 7, 8, 9,10, 11, 12, 13, 14, 15A, 15B, 15C and 15D for connecting the outersheath handle 710 to the inner screw handle 720 is illustrated in FIGS.16 to 23. These figures illustrate a delivery system 1600 that aids inthe controlled, accurate deployment of a stent graft. This configurationadds mechanical advantage to the retraction of the introducer sheath,which allows for a “smooth” retraction of the outer sheath by notpermitting the build up of potential energy, stored in the compressedstent graft, to cause an unexpected jumping or jerking motion duringouter sheath retraction.

A distal engagement portion 1612 of the outer sheath handle 1610 has aninternally threaded bore for receiving therein a threaded portion 1622of the inner screw handle 1620. In an exemplary embodiment, the distalengagement portion 1612 is made of DELRIN®. Engagement of the outersheath handle 1610 to the inner screw handle 720 (FIG. 7) is made byturning the outer sheath handle 1610 with respect to the inner screwhandle 1620. This causes the outer sheath handle 1610 to retract over orextend from the distal end of the inner screw handle 1620 in acontrolled fashion. Turning can be assisted with a proximal turn knob1624 rotationally fixed to the inner screw handle 1620.

The threaded portion 1622 extends for a longitudinal length that isgreater than the amount that is necessary to overcome greatest forcerequired for stent graft deployment. Once that greatest point of forceis overcome, the chance of handle jerk or slippage decreases and,therefore, the two handle portions 1610, 1620 can be movedlongitudinally freely with respect to one another. To achieve thetransition from longitudinal controlled and slow movement tolongitudinal free movement (and speedy if desired), at the proximal endof the threads of the inner screw handle 1620, a channel 1626 (or morechannels, e.g., two opposing channels) can be cut into the inner screwhandle 1620. A non-illustrated set screw is located at the distalengagement portion 1612 to protrude into the interior and engage thethreaded portion 1622. When the two handle portions 1610, 1620 arerotated sufficiently far to move the interiorly projecting set screwproximal of the threaded portion 1622, the set screw will ride directlyinto the channel 1626 (or the set screws directly into the channels1626). A set screw is desirable in this configuration because it can beused to increase and decrease tension for rotating the two handleportions 1610, 1620 with respect to one another. Changing the forceimparted against the threaded portion 1622 can be accomplished bydecreasing/increasing the depth of the set screw into the distalengagement portion 1612.

Functioning of the delivery system 1600 is illustrated, for example, inthe diagrams of FIGS. 20 to 23. Before the inner screw handle 1620 isturned to retract the outer sheath handle 1610, the outer sheathcatheter 2010 completely covers the stent graft 2020, which is loadedtherein just behind (proximal of) the nose cone 2030. The turn knob 1624is rotated to move the outer sheath handle 1610 proximally and begin todeploy the stent graft 2020 from the outer sheath catheter 2010. Theuser holds the inner screw handle 1620 longitudinally stationary whileturning so that the outer sheath catheter 2010 moves proximally. Anembodiment of the step is shown in FIG. 21. Once the channels 1626 arecompletely disengaged from distal engagement portion 1612 of the outersheath handle 1610, the outer sheath handle 1610 will rotationally lockinto the channel(s) 1626 while still being longitudinally free to movewith respect to the inner screw handle 1620. At this point, the barestent 2110 and the first sealing stent 2120 are exposed. After channellock occurs, the proximal end of the stent graft 2020 is exposed fromthe outer sheath catheter 2010 as shown in FIG. 21. With the setscrew(s) locked into the channel(s) 1624, the outer sheath handle 1610can no longer rotate with respect to the inner screw handle 1620 and,now, can be moved proximally as desired by the user. Accordingly, theouter sheath catheter 2010 can be retracted so that the entire body ofthe stent graft 2020 is exposed as shown in FIG. 22. At this point, theouter sheath handle 1610 is positioned over the inner screw handle 1620and up to the turn knob 1624 and the stent graft 2020 is only held tothe delivery system 1600 by the apex clasp device 2210. With release ofthe apex clasp device 2210, the stent graft 2020 is freed from thedelivery system 1600 and, thereafter, the delivery system 1600 can beremoved from the patient without impacting the implantation of the stentgraft 2020.

The delivery system 1600 of FIGS. 16 to 23 can be loaded with a 28mm×150 mm graft into a 19.5 French OD braided introducer sheath, forexample. In this configuration, the delivery system 1600 can deploy thebifurcated stent graft 2020 utilizing the mechanical advantage appliedby the screw mechanism to release the first section of the graft (barestent 2110 and sealing stent 2120). The remainder of the stent graft2020 can, then, be deployed by the pin-and-pull assembly of the deviceafter the channels 1626 are disengaged. This configuration eliminatesany requirement to have the physician actively disengage the threads.

A further alternative to the two- or multi-part controlled deployment ofFIGS. 7 through 23 is illustrated in FIGS. 24 through 32. In general,these figures describe a “jogged slot” handle that aids in thecontrolled, accurate deployment of a stent graft. As set forth above,handles to be used on the delivery system of an AAA device need to gainbetter control over placement accuracy and/or to better fixate the AAAgraft during graft placement. The present invention provides a “joggedslot” (which can be configured in a similar manner as an automatictransmission shifter slot (i.e., stair steps)) to improve placementaccuracy. The “jogged slot” in this example utilizes stent graftdelivery system features described in the family of applicationsbeginning with U.S. Provisional Patent Application Ser. No. 60,499/652,filed Sep. 3, 2003, and U.S. patent application Ser. No. 10/784,462,filed Feb. 23, 2004, incorporated herein and including a slottedaluminum handle body, a distal handle grip, a proximal handle grip andthe proximal clasp assembly. The invention, however, is not limited tothis particular embodiment. If desired, the actuation knob can bereplaced with an end cap that serves to fixate the internal hypotube.

As shown in FIGS. 24 and 25, the internal mechanism of the deliverysystem 2400 includes an internal tube 2500 with a jogged slot 2510 inwhich the slider assembly 2600 (FIG. 26) can slide from the distalportion of the delivery system 2400 (shown in FIG. 24) to the proximalportion of the delivery system 2400 during stent graft deployment.During deployment of the stent graft, the delivery system 2400 with thejogged slot 2510 only permits the handle parts to move to a particularextent that is less than the total movement required for completedeployment of the stent graft. The jog 2512 or “Z” in the slot 2510 hasa circumferential or transverse portion 2514 preventing the proximalhandle grip 2410 from moving all the way back to the end cap 2420without first having to be rotated circumferentially/transversely aroundthe jog 2512. FIGS. 26 and 27 show that the slider assembly 2600 can be,in an exemplary embodiment, a cylindrical hub with a barbed fitting atits distal end to receive the outer stent sheath 2610. At the proximalend of the slider assembly 2600 is an o-ring through which the supportmember hypotube passes. The slider assembly 2600 serves as both anattachment point for the outer stent sheath 2610 to the handle and as ahemostasis port for flushing of the sheath catheter. Exiting from theside of the slider assembly 2600 is a “boss” 2700 that extends outward,through the slot 2442 in the handle body 2440, and attaches to theproximal handle grip 2410. The flush port runs through this boss 2700and attaches to the flush port tubing and valve 2710.

FIGS. 28 to 30 illustrate the attachment of the slider assembly 2600 tothe proximal handle grip 2410, which attachment allows actuation of thedelivery system 2400 and deployment of the stent graft from the outerstent sheath 2610. The outer stent sheath 2610, which is attached to theslider assembly 2600, is retracted in a proximal sliding motion(indicated by arrows A in FIG. 28) over the stent graft. Morespecifically, in this exemplary embodiment, the distal handle 2430 isheld stationary while the proximal handle grip 2410 is moved back(proximally) to deploy the stent graft. The internal support member thatis located coaxially within the outer stent sheath 2610 (see FIGS. 29and 30) serves as a platform or anchor to prevent the stent graft fromretracting along with the outer stent sheath 2610.

Significantly, the internal tube 2500 of the delivery system 2400provides advantages to permit controlled deployment (unsheathing) of thestent graft. The internal tube 2500 in this exemplary embodiment is madefrom polycarbonate material and is sized so that it can move freelywithin the slotted aluminum handle body 2440. The slider assembly 2600is sized so that it can move freely within the internal tube 2500. Theinternal tube 2500 has a straight tube running the full length of thedelivery system 2400. Machined through the wall of the internal tube2500 is the slot 2510 which is “jogged” in the manner of an automobiletransmission shifter. As such, the circumferential or transverse portion2514 of the jogged slot 2510 provides a so-called stop (or stops) thatcontrol deployment of the stent graft at different points during thestent graft deployment sequence. The jog(s) 2512 that is/are cut intothe internal tube 2500 only allows the slider assembly 2600 to movewithin that particular jog segment of the internal tube 2500. Furtherretraction of the outer stent sheath 2610 requires the user to activelyturn the end cap 2420 to a next setting, thus allowing further proximalmovement of the slider assembly 2600. The boss 2700 of the sliderassembly extends through the jogged slot 2510 of the internal tube 2500and through the slot 2442 of the handle body 2440. The boss 2700 is,then, connected to the proximal handle grip 2410. The internal tube 2500is attached at the distal end of the delivery system 2400 to the distalhandle 2430. Rotation of the distal handle 2430 allows rotation of theinternal tube 2500 within the handle body 2440.

FIGS. 31 and 32 show one exemplary embodiment for indicating a positionof the internal tube 2500 in the various stop positions. The indicatorcan be realized through either a viewing window 3200 withnumbers/letters or by color coded dots. From the package in which thesystem is delivered, the delivery system 2400 can be in a lockedposition (indicated, for example, with an “L”) of the jogged slot 2510.In this orientation, the clinician could remove the delivery system 2400from the package and perform flushing procedures without a concern ofprematurely deploying the stent graft during handling. The cliniciankeeps the delivery system 2400 in the locked position/state duringinsertion of the device into the patient's artery and while tracking tothe site of stent graft deployment. The stop mechanism prevents anypossibility of inadvertent proximal movement of the outer stent sheath2610, which could partially deploy the stent graft.

Once the clinician identifies the deployment site and is ready to deploythe stent graft, he/she turns the distal handle 2430 until, for example,stop position 1 is obtained. With the device in stop position 1, thejogged slot 2510 of the internal tube 2500 and the slot 2442 of thehandle body 2440 will be aligned, thus allowing the proximal handle grip2410 to be slid proximally to allow partial stent graft deployment.Positioning of the next exemplary jog or stop on the internal tube 2500is set so that the supra-renal struts and at least two stent graftsprings (i.e., stents) are deployed from the outer stent sheath 2610.With the stent graft partially deployed, but with the suprarenal struts(i.e., of the bare stent) still captured in the distal clasp mechanism,the stent graft can still be maneuvered proximally or distally withinthe aorta to establish sealing site positioning.

At this point, the clinician can fix the delivery system 2400 relativeto the patient to maintain the stent graft position relative to theaorta. Then, the clinician can move the distal handle 2430 to stopposition 2 and continue to move the proximal handle grip 2410 in aproximal direction until, for example, the contralateral leg of abifurcated stent graft is released from the outer stent sheath 2610. Thestop on the delivery system 2400 at the end of stop position 2 can, inan exemplary embodiment, prevent the ipsilateral leg from deploying fromthe outer stent sheath 2610. Then, the clinician can rotate the deliverysystem 2400 to orient the stent graft's contralateral leg to align withthe patient's arterial anatomy. Once the stent graft is orientedproperly, the clinician can actuate the distal clasp assembly andrelease the suprarenal struts. The captured ipsilateral leg, along withthe anchored supra-renal strut and proximal seal serve as fixationduring crossing of the guidewire into the contralateral leg andsubsequent placement of the contralateral leg graft placement. Oncecontralateral leg graft placement is achieved, the delivery system 2400is moved to stop position 3 and the proximal handle grip 2410 is pushedproximally to fully release the stent graft. The particularplacement/configuration of the stop positions is determined based uponvarious factors, including the size of the prosthesis and the featuresof the vessel in which the prosthesis is to be placed.

Yet another alternative to the multi-step controlled deployment of FIGS.7 to 32 is illustrated in FIGS. 33 to 51. These figures describe, ingeneral, an internal lead screw handle that aids in the controlled,accurate deployment of a stent graft. As indicated above, it isdesirable to gain better control over placement accuracy of an AAA graftduring stent graft placement with an AAA delivery system. The internallead screw embodiment described herein increases placement accuracy byallowing the operator to have more control over the initial deploymentof the stent graft.

An exemplary embodiment of a delivery system 3300 with an internal leadscrew that deploys a stent graft from a sheath is shown beginning withFIG. 33 and ending with FIG. 51. The delivery system 3300 has aninternal lead screw 3310 (see FIGS. 34, 35, 37), a lead screw nut 3320(see FIGS. 35 and 37), a lead screw rail 3330 (see FIGS. 36 and 37), adistal handle grip 3340, a flush port and a proximal end cap 3350. Thisconfiguration utilizes a support member 3360 with a hypotube at itsproximal end and a distal clasp assembly similar to the stent graftdelivery system described in the patent family previously incorporatedherein by reference. The lead screw nut 3320 can be actuated indifferent ways to deploy the stent graft from the outer sheath 3370. Oneexemplary actuation rotates the lead screw nut slowly to pull back onthe outer sheath 3370 using the threads of the internal lead screw 3310.Another exemplary actuation simply pulls back on the lead screw nut 3320to deploy the stent graft. By housing the internal lead screw 3310(which is formed, in this example, from cutting material on outerportions of a round threaded screw to a rectangular cross-section withthreads on only one side, i.e., a partial lead screw) within the leadscrew rail 3330, the system can bypass the need to always use the firstexemplary actuation process.

The support member 3360 is coaxially contained within the deliverysystem 3300. The support member 3360 is attached at its proximal end tothe proximal end cap 3350 of the delivery system 3300. The supportmember 3360 travels coaxially through the internal lead screw 3310, theflush port, and the outer sheath 3370. At the distal end of the supportmember 3360 is a capture pod that holds the proximal (caudal) end of thestent graft. A guidewire catheter and the distal clasp assembly tubing(FIG. 39) travel coaxially within the support member 3360 along the fulllength of the delivery system 3300. Contained within the distal end ofthe outer sheath 3370 can be the crimped stent graft and the distalclasp assembly. The distal clasp assembly terminates at the distal endwith a flexible tip 4100, shown in FIG. 41.

The internal lead screw 3310 (FIG. 33) used in this exemplary embodimentcan be made from a 1-inch diameter lead screw with a 0.400 inch linearlead per rotation of the lead screw nut. The internal lead screw 3310 isapproximately 14 cm in length and is machined so that most of thethreads are cut away from the circumference. Machining of the internallead screw 3310 is performed to allow the internal lead screw 3310 tofit in the lead screw rail 3330 and to allow the lead screw rail 3330 tofit between the internal lead screw 3310 and the lead screw nut 3320.The lead screw rail 3330 acts to center the lead screw nut 3320 on thepartial internal lead screw 3310. The diameter of the lead screw rail3330 is approximately equivalent to the minor diameter of the lead screwnut 3320. By locating the lead screw rail 3330 in this configuration,the internal lead screw 3310 can slide within the groove 3530 of thelead screw rail 3330 (FIG. 35).

Attached to the distal end of the internal lead screw 3310 is a flushport (FIG. 38). An O-ring is contained in the proximal end of the flushport, which seals around the support member hypotube. At the distal endof the flush port is a nipple that attaches to the outer sheath 3370.

During assembly of the delivery system 3300 (shown, in part, in FIGS. 39to 41), the stent graft is first loaded into the outer sheath 3370 alongwith the distal clasp assembly and the guidewire catheter. Then, theflexible tip 4100 is threaded onto the distal clasp assembly. As shownin FIGS. 42 and 43, the pre-assembled support member 3360 is then loadedinto the outer sheath 3370. Then, the support member 3360 is guidedthrough the flush port and the internal lead screw 3310. The outersheath 3370 is, then, attached to the flush port and is clamped (seeFIG. 38). As shown in FIG. 44, the handle body is assembled by firstattaching the distal handle grip 3340 to the lead screw rail 3330. Then,as shown in FIGS. 45 to 46, the sub-assembly of the outer sheath3370/flush port/internal lead screw 3310 is threaded through the openingin the front of the distal handle grip 3340 and the internal lead screw3310 is set in the groove 3530 of the lead screw rail 3330. FIGS. 47 to48 show that the lead screw nut 3320 is passed over the lead screw rail3330 and mated with the internal lead screw 3310. The outer sheath 3370is moved forward and the lead screw nut 3320 is threaded forward untilit contacts the distal handle grip 3340. As illustrated in FIGS. 49 to51, the proximal end cap 3350 is, then, placed over the support member3360 and attached to the lead screw rail 3330. The support member 3360is secured to the proximal end cap 3350 and the distal clasp mechanismhardware is installed.

In use, the clinician first flushes the delivery system 3300 by forcingsaline through the flush port. The saline fills the annular spacebetween the outer sheath 3370 and the support member 3360, permeatesthrough the crimped stent graft, and exits between the outer sheath 3370and the flexible tip 4100. The o-ring in the flush port seals thehypotube of the support member 3360 and prevents leakage through thedelivery system 3300. Then, the clinician feeds the delivery system 3300over an indwelling guidewire and tracks the device to the stent graftdeployment site.

At this point, the clinician has the option to either slowly release thestent graft by rotating the lead screw nut 3320 or rapidly release thestent graft by pulling back on lead screw nut 3320 and, thereby, slidingthe internal lead screw 3310 down the lead screw rail 3330. At somepoint in the deployment of the stent graft, the release can be stoppedto actuate the distal clasp assembly and release the leading struts(bare stent) of the stent graft. Because the stent graft is usuallyseverely constrained within the outer sheath 3370, deployment forceswith AAA devices can be quite high.

The internal lead screw of the invention has the advantage ofincorporating a screw system to convert the linear force to a torqueforce. The torque force that the clinician must exert on the lead screwnut to deploy the stent graft is ergonomically less difficult than thelinear pull force. In addition to the mechanical advantage obtained withthe lead screw nut, the screw type mechanism allows for greater controlin the release of the stent graft. In a linear pin-and-pull system, thelargest force to deploy the stent graft is at the initial release offriction between the stent graft and the sheath. As soon as that initialfriction is overcome, the deployment force quickly declines. From anergonomic point of view, it is very difficult for a clinician tomaintain control and speed of the deployment at the moment when thefrictional forces are overcome. It is very common for the stent graft tobe un-sheathed more than was desired due to this loss of control. Ascrew type mechanism according to the present exemplary embodimentallows the clinician to have more control over this initial release ofthe stent graft, which is a critical factor for stent placementaccuracy.

FIGS. 52 to 54 illustrate an improvement to the lead screw embodiment ofthe previous figures. In the above embodiment, the user was required togrip and turn the handle knob with one hand while holding the sheathhandle grip with the other hand. See FIG. 52. Actuation of this handlerequired the user to concentrate on two motions at once for deploymentof the stent graft. Also, there was a possibility of turning thehypotube/inner member out of alignment with the sheath hub, whichmisalignment could decrease stent graft placement accuracy. Therefore, asecond handle 5300 was added behind (proximal) the turn knob 5310 (FIGS.53 and 54). The second handle 5300 is attached to the bearing engagementthat is affixed to the inner member 5360 (hypotube). The user grips thesecond handle 5300 and turns the lead screw knob with the thumb andpointer finger. Now, the user's hand is pinned in one location as theknob is turned and the sheath handle is retracted back over the leadscrew.

FIGS. 55A through 57 illustrate another exemplary embodiment of thedelivery systems of the present invention. This example of the deliverysystem 5500 includes features of the pin-and-pull telescopic systems100, 700, 1600, 2400 and the delivery system 3300. The delivery system5500 has an internal lead screw 5510, a lead screw nut 5520, a hollowdistal grip handle (also referred to herein as “distal grip”) 5530, anda hollow interior body 5540 (also referred to herein as “handle body”).The internal lead screw (also referred to herein as “internal lead screwassembly”) 5510 rides within a track 5542 of the hollow interior body5540. The lead screw nut 5520 has a non-illustrated interior threadhaving a pitch corresponding to upper thread portions (also referred toherein as “threaded portion”) 5512 to cause longitudinal movement of theinternal lead screw 5510 when rotated about the hollow interior body5540. Thus, the lead screw nut 5520 is rotatably freely mounted aboutthe hollow interior body 5540. The lead screw nut 5520 is alsolongitudinally freely mounted about the hollow interior body (alsoreferred to herein as “handle body”) 5540. In this configuration, theclinician has the ability to rotate the lead screw nut 5520 to anydesired retraction of the internal lead screw 5510. At any time before,during, or after such rotation, the clinician can move the lead screwnut 5520 longitudinally proximal, taking the internal lead screw 5510along with it at the same speed of proximal movement of the lead screwnut 5520. The internal lead screw 5510 is longitudinally fixed to theouter sheath 5550, which is longitudinally free from the hollow distalgrip handle 5530 and the hollow interior body 5540. In this manner,rotation of the lead screw nut 5520 moves the outer sheath 5550relatively slowly (dependent upon the pitch of the upper thread portion5512), and longitudinal movement of the lead screw nut 5520 moves theouter sheath 5550 relatively fast.

The difference between FIGS. 55A and 56 illustrates the relativepositions of the internal lead screw 5510, the hollow distal grip handle5530, the hollow interior body 5540, and the outer sheath 5550 after thelead screw nut 5520 has been moved proximally to (about) itsproximal-most position. In FIG. 55A, the outer sheath 5550 surrounds thepush rod 5560 and completely covers the cavity within the outer sheath5550 in which the non-illustrated stent graft is stored (compressed)prior to implantation. The outer sheath 5550 extends all the way totouch the nose cone 5570 and form a seal therewith to reliably securethe stent graft therein. In FIG. 56, in comparison, the outer sheath5550 can be seen completely retracted from the nose cone 5570 to clearthe indented boss 7000 at the distal end of the push rod 5560. The apexcapture assembly 5568 for removably securing the bare stent (e.g., 2310)of the stent graft is shown just proximal of the nose cone 5570 and inthe closed (secured) position of the apex capture assembly 5568.Actuation of the apex release device 5580 moves the inner catheter 5590connected to the proximal apex capture portion 5572 (with itsbare-stent-capturing tines) proximally to create a space through whichthe individual proximal apices of the bare stent can escape.

It is noted that the entire device disposed in the interior of thehollow distal grip handle 5530 shown in FIG. 55A is not shown in FIG.56. This device, slider 5700, is shown, in enlarged detail, in FIG. 57A.From distal to proximal, the outer sheath 5550 is secured by a sheathclip 5702 to a distal nipple of a slider cap 5710. The slider cap 5710has a check or flush valve (also referred to herein as “flush valveorifice”) 5712 fluidically connecting the inner chamber of the slidercap 5710 to the environment outside the flush valve orifice 5712. Anintermediate slider body assembly (also referred to herein as “sliderbody”) 5720 is secured to the slider cap 5710 with an o-ring 5730therebetween to keep the respective interior chamber fluidicallyconnected to one another and fluidically sealed from the environmentoutside the two parts slider cap 5710, and slider body assembly 5720.

A release 5514 (e.g., a thumbscrew) removably secures the slider 5700inside the hollow distal grip handle 5530 and hollow interior body 5540when the release is placed inside a blind hole 5722 of the slider bodyassembly 5720. With the release 5514 removed/actuated, all of the partsillustrated in FIG. 56 can be removed from the slider 5700 except forthe outer sheath (also referred to herein “sheath”) 5550—this includesthe entire distal section with the support member 5740, the apex releasedevice 5580 and the nose cone 5570.

As the above delivery systems, a support member 5740 runs entirelythrough the slider body assembly 5720 and all the way back to the apexrelease device 5580. This support member 5740 needs to be sealed to theslider 5700 so that blood flow outside the member is not allowed. Toeffect this seal, a wiper gasket seal (also referred to herein as “wipervalve”) 5750 is provided inside the cavity of the slider body assembly5720. The seal is enhanced with the use of an x-valve assembly 5760.

The apex capture device assembly of the invention can be employed inconjunction with the leg clasp of the invention, as shown in FIG. 128.The catheter 8613 and elongate member 8614 extends from apex capturedelivery device assembly 12802 through leg clasp 12810. Bifurcated stentgraft 12803 extends from apex capture device 12804 to leg clasp 12810,and is secured at each of apex capture device 12804 and at leg clasp12810 as described above, and for release according to the method of theinvention, as also described above.

In an embodiment, the invention is a stent graft delivery device,comprising, an apex capture device assembly, including (1) a proximalapex capture portion, including a nose, wherein the nose defines atleast one radial restraint that is substantially parallel to a majoraxis of the proximal capture portion; and a plurality of tines extendingdistally from the nose, the tines radially distributed about the majoraxis radial to a most proximal radial restraint and substantiallyparallel to the major axis, (2) a distal apex capture portion definingslots distributed radially about the major axis, the slots mateable withthe times by relative movement of the proximal and distal apex captureportions along the major axis, (3) a plurality of bosses extendingradially from the major axis between the nose and the distal apexcapture portion and aligned with the slots along the major axis innon-interfering relation with movement of the tines into mating relationwith the slots, (4) an elongate member 8614, otherwise known as an innercontrol tube, to which the distal apex capture portion is fixed, theelongate member extending through the proximal apex capture portion andthe plurality of bosses, (5) a catheter 8613, otherwise referred to asan outer control tube, to which the proximal apex capture portion isfixed, through which the elongate member extends, whereby movement ofthe catheter causes movement of the proximal apex portion along themajor axis between a first position, in which the tines are mated withthe slots and overlie the bosses, and a second position, in which thetines are not mated with the slots and do not overlie the bosses, (6) abare stent that includes struts linked by apices, the struts extendingbetween the tines, a portion of the apices extending between the bossesand the distal apex capture portion when the tines are mated to theslots and (7) at least one suprarenal barb extending from the stent intothe radial restraint; and a leg clasp through which the elongate memberand catheter extend, the leg clasp including, (1) a barrel, (2) a spoolextending from the barrel along a major axis of the barrel, and (3) arim at an end of the spool, the rim having a diameter greater than thatof the spool but less than that of the barrel.

In another embodiment, the invention is an x-valve assembly, comprisingan x-valve; and a gasket supporting the x-valve. The gasket includes aperipherial support and at least one arm extending inwardly from theperipherial support. In an embodiment, the gasket includes at least twopairs of arms, along intersecting major axes. In an embodiment, eachpair of arms is aligned. At least two of the axes of the x-valveassembly can be normal to each other. The pairs of arms in the x-valveassembly can lie in a plane. The gasket of the x-valve assembly caninclude a superelastic metal, which can include nitinol.

X-valve assembly 5760 can be seen in greater detail in FIG. 57B. Asshown therein, x-valve assembly 5760 includes gasket support 5762 andvalve 5764. Gasket support 5762 is shown separately in FIG. 57C. Gasketsupport 5762 typically includes superelastic metal, such as nickeltitanium (i.e., nitinol). Valve 5764 is shown separately in FIG. 57D.Valve 5764 typically is formed of silicone. A partially exploded view ofx-valve assembly 5760 slider body assembly 5720 is shown in FIG. 57E.Another perspective of a partially exploded view of x-valve assembly5760 in slider body assembly 5720 is shown in FIG. 57F. Slider bodyassembly 5720 components shown in FIGS. 57E and 57F include slider body5766 and gasket spacer 5768. The slider body and gasket spacer typicallyformed of polyetheretherketone (PEEK). With this configuration, when thesupport member 5740 is in the slider 5700 as shown in FIG. 57A, bloodflow outside the slider 5700 is substantially prevented when theproximal end of the support member 5740 is sealed). The flush valveorifice 5712, therefore, is the only way for blood flow to occur, butonly if the blood surrounds the support member 5740.

As set forth above, the support member 5740 can be removed from withinthe slider 5700. While the wiper valve 5750 and the x-valve assembly5760 form some or even a substantial measure of sealing capability, theblood-tight seal needs to be ensured. Accordingly, a sealing assembly isprovided at the proximal end of the slider 5700, which sealing assemblyis comprised, in one exemplary embodiment, of a sheath valve 5770, asheath valve washer 5780, and a sheath valve knob 5790. As described inthe following text, the sheath valve washer 5780 is not necessary but isincluded in this embodiment. The sheath valve 5770 here is formed as acylindrical piece of silicone but can take any shape or material so longas, when compressed inside the slider body assembly 5720, it creates ablood-tight seal inside the blind hole 5722 of the slider body assembly5720. With the configuration shown in FIG. 57A, the sheath valve knob5790 is connected into the proximal end of the slider body assembly(also referred to herein as “slider body”) 5720 with a thread so that,when rotated with respect to the slide assembly 5720, the sheath valveknob 5790 enters into or removes therefrom. Thus, after removal of theinterior assemblage, (as the nose cone is being withdrawn from theslider body assembly 5720, with appropriate rotation, the knob 5790pushes the sheath valve washer 5780 inwards against the sheath valve5770 to compress the sheath valve 5770 on itself and seal up the holeleft after the support member 5740 and all of the interior assemblage isremoved. In a particular embodiment of the sheath valve 5770, an annulargroove 5772 on the outside diameter of an intermediate portion of thesheath valve improves a self-sealing collapse of the sheath valve 5770.Easier collapse is desired because of the strain that the userexperiences when having to rotate the sheath valve knob 5790 withgreater resistance. The groove 5772 significantly reduces the forcerequired and the number of knob turns required.

FIGS. 58 to 60 illustrate exemplary embodiments of the nose cone of thedelivery systems of the present invention.

A passive hemostasis valve for the delivery systems 100, 700, 1600,2400, 3300, 5500 can replace the sheath valve 5770 in the slider 5700 ofFIG. 57A. Hemostasis can be maintained by two components. First, a sealon the guidewire can be made by a “duckbill” type valve. The duckbillcan have mechanical assist, for example, such as by two spring-loadedrollers, to ensure the seal. The seal on the sheath of the second deviceis maintained by a rubber disc having a hole slightly smaller than thesheath it will receive. This component also maintains hemostasis for themain system.

FIGS. 65 to 69 illustrate an exemplary embodiment of a leg-extensiondelivery system according to the invention (as compared to the main orbifurcated delivery system as shown, for example, in FIGS. 55A to 57.The measurements shown in these figures are not to be taken as the onlyembodiment and, instead, should be taken as only exemplary for theinvention.

The above-described delivery systems 100, 700, 1600, 2400, 3300, 5500each require the stent graft to be loaded within the outer sheathcatheter and each have an interior device that both prevents the stentgraft from being inserted too far into the outer sheath catheter andkeeps the stent graft longitudinally fixed when the outer sheath isbeing retracted over the stent graft. When implanting a bifurcated stentgraft, it is desirable to ensure that the last two springs (e.g.,stents) of the ipsilateral leg are not prematurely released from theouter sheath during deployment. The invention, shown in FIGS. 70A, 70Band 70C, allows the capture of the stent graft's ipsilateral leg whilethe contralateral leg is cannulated. Such a configuration ensuresstability of the stent graft during the cannulation of the contralateralleg.

An additional embodiment of the invention shown in FIGS. 70A, 70B and70C, as an example, is a leg clasp 7001, comprising a barrel 7002; aspool 7004 extending from the barrel 7002 along a major axis of thebarrel 7002; and a rim 7006 at an end of the spool 7004, the rim 7006having a diameter greater than that of the spool 7004 but less than thatof the barrel 7002, as shown in FIGS. 70A, 70B and 70C.

The leg clasp 7001 of the invention can formed, at least in part, of atleast one component selected from the group consisting of stainlesssteel, polyester, polyetheretherketone (PEEK) and acrylonitrilebutadiene styrene (ABS). The rim 7006 of the leg clasp 7001 of theinvention can include radially extending spokes 12502, as shown in FIGS.125 and 126.

In still another embodiment, the invention is a stent graft deliverysystem, comprising a leg clasp 7001 that includes a barrel 7002, a spool7004 extending from the barrel 7002 along a major axis of the barrel7002 and a rim 7006 at an end of the spool 7004, the rim 7006 having adiameter greater than that of the spool 7004 but less than that of thebarrel 7002; a support tube 7010 fixed to the barrel 7002 and extendingfrom the barrel 7002 in a direction opposite that of the spool 7004; andan outer sheath 7030 (FIGS. 70A and 70C) having an internal diameterrelative to that of the barrel to permit movement between a firstposition that covers the spool 7004 and rim 7006 and a second positionthat exposes the spool 7004 and rim 7006. It is to be understood thatsupport tube 7010 is also represented as support tube 5744 in FIG. 57A,and that, in an alternative embodiment, some other component of supportmember 5740, shown in FIG. 57A, can be fixed to barrel 7002, such ashypo-tube 5742, also shown in FIG. 57A, and that support tube 7010 canbe fixed directly to hollow interior body 5540, shown in FIG. 56.

The stent graft delivery system of the invention can further include astent graft 7020, wherein a distal most stent 7024 of the stent graftextends about the spool 7004 in interfering relation with the rim 7006when the outer sheath 7030 is in the first position, and a tubular graftcomponent 7032 to which the stent is fixed extends between the rim andthe sheath, whereby movement of the sheath from the first to the secondposition releases the stent graft from the leg clasp.

In particular, an indented boss 7000 is placed at the distal end of thepush rod (also referred to herein as “support tube”) 7010, whichprevents the stent graft 7020 from being inserted too far into the outersheath 7030 and keeps the stent graft 7020 longitudinally fixed when theouter sheath 7030 is being retracted over the stent graft 7020. Theindented boss 7000 has a proximal flange (also referred to herein as a“barrel”) 7002, an intermediate span (also referred to herein as a“spool”) 7004, and a distal flange (also referred herein as a “rim”)7006. The outer diameters of the proximal and distal flanges 7002, 7006are larger than the outer diameter of the intermediate span 7004 tocreate an annular cavity 7008 therebetween. If the stent graft leg 7022is placed over the distal flange 7006 sufficiently far to have thedistal-most stent 7024 within the annular cavity 7008, the indented boss7000 creates an interference fit between the stent graft leg 7022 andthe outer sheath 7030. Once the outer sheath 7030 is completelyretracted, the interference fit disappears. It can be said that thefixation of the distal-most stent 7024 is passive due to the fact that,after the outer sheath 7030 is retracted, the fixation is lost. Thisconfiguration can be used to better control and grasp the stent graft7020 by preventing longitudinal movement thereof when the outer sheath7030 is retracted (to the left of FIG. 70A).

The following sections discuss improvements to stent grafts, inparticular, bifurcated AAA stent grafts intended to span the renalarteries. As shown in FIGS. 72A, 72B, 72C through FIG. 83, a stent graftsystem, such as bifurcated stent graft system 7200, comprising a tubulargraft component 7201; a bare stent component 7210 including a pluralityof struts 7211 joined by proximal apices 7212 and distal apices 7213connecting the struts 7211, the bare stent component 7210 fixed to aproximal end 7214 of the tubular graft component 7201 and extendingproximally from the proximal end 7214; an infrarenal stent component7215 proximate to the bare stent component 7210, wherein the infrarenalstent component 7215 is distal to the bare stent component 7210 andspans a circumferential line defined by distal apices 7213 of the barestent component 7210 fixed to the tubular graft component 7201; at leastone suprarenal barb 7220 extending distally from at least one suprarenalportion 7217 of the bare stent component 7210; and at least oneinfrarenal barb 7230 extending distally from at least one infrarenalportion 7218 of the bare stent component 7210.

“Suprarenal,” as used herein in reference to a barb, means a barb thatattaches to the aorta cranial to the ostium of the most superior renalartery.

“Infrarenal,” as used herein in reference to a barb, means a barb thatattaches to the aorta caudal to the ostium of the most inferior renalartery.

In another embodiment, an infrarenal barb can be a first covered barb.Bare stent is also referred to as “uncovered” or “partially” coveredstent.

“Barb” is also referred to herein as “hook.”

As shown in FIG. 73, in the stent graft system of the invention, thesuprarenal portion of the bare stent 7210 can include a bridge 7219between struts 7211 to define an eyelet 7221 that joins two struts 7211,and wherein the suprarenal barb 7220 extends from the bridge 7219.

The infrarenal barb 7230 of the stent graft system of the invention canextend from a distal apex 7213 that joins two struts 7211.

Exemplary distances between the most proximal point of the suprarenaland infrarenal barbs of the stent graft system of the invention is in arange of between about 6 mm and about 40 mm (e.g., 6 mm, 10 mm, 15 mm,20 mm, 25 mm, 30 mm, 35 mm, 40 mm).

At least one of the stents of the stent graft system of the inventioncan include a superelastic metal, such as nickel titanium.

In an embodiment, the distal apices of a bare stent of the stent graftsystem of the invention are fixed within the tubular graft component andwherein the infrarenal barb extends from the bare stent through thetubular graft component. At least one infrarenal stent of the inventioncan be fixed within the luminal graft component.

Another embodiment of the invention, shown in FIG. 105C is a stent graftsystem 10550, comprising a tubular graft component 10560; a bare stent10570 of angled struts 10580 joined by proximal apices 10590 and distalapices 10591, and extending from a proximal end 10592 of the tubulargraft component 10560; a proximal stent 10593 adjacent the bare stent10570 and within the tubular graft component 10560, the proximal stent10593 nested with the bare stent 10570; and at least one barb 10594extending distally from a distal apex 10591 and through the tubulargraft component 10560.

FIG. 71 diagrammatically illustrates an abdominal aorta 7100 with ananeurysm 7110 between the renal arteries 7120 and the iliac arteries7130—the abdominal aorta 7100 branches, at its downstream end, andbecomes the left and right common iliac arteries 7130, carrying blood tothe pelvis and legs. FIGS. 72A, 72B and 72C diagrammatically illustratesa stent graft system, such as a bifurcated stent graft system 7200having a graft portion that extends from just downstream of the renalarteries 7120 towards the iliac arteries 7130, splitting into twosmaller graft portions, one of which extends into an iliac artery 7130and the other ending before the other iliac artery 7130. The bare stent7210 of this bifurcated stent graft system 7200 is configured with bothsuprarenal barbs 7220 and infrarenal barbs 7230.

Another embodiment, shown in FIG. 72B the invention is a bifurcatedstent graft system 7200, comprising a tubular graft component 7201; abare stent 7210 extending from a proximal end 7214 of the tubular graftcomponent 7201, such as a bifurcated tubular graft component; at leastone suprarenal barb 7220 extending distally from a suprarenal portion7217 of the bare stent 7210; and at least one infrarenal barb 7230extending distally from an infrarenal portion 7218 of the bare stent7210, the distance, a, between the suprarenal barb 7220 and infrarenalbarb 7230 along a major axis of the tubular graft component being in arange of between about 6 mm and about 40 mm (e.g., 6 mm, 10 mm, 15 mm,20 mm, 25 mm, 30 mm, 35 mm, 40 mm).

In the stent graft system of the invention, at least a portion of thebarbs extend from the bare stent at an angle in a range of between about20 degrees and about 60 degrees (e.g., 20 degrees, 25 degrees, 30degrees, 35 degrees, 40 degrees, 45 degrees, 50 degrees, 55 degrees, 60degrees).

A bare stent of the stent graft system of the invention can be formed,at least in part, of a superelastic metal.

As shown in FIGS. 78A, 78B, 78C, 79A, 79B and 79C, the stent graftsystems of the invention can further include at least one radiopaquemarker 7800. At least one radiopaque marker attached to the stent graftsystems of the invention, either to the stent or the graft material, canaid in the place of the stent graft in a patient by employing stentgraft delivery systems of the invention, for example, in methods oftreating abdominal aortic aneurysms.

FIGS. 73 to 75 illustrate various features of a bare stent component7210 with hooks or barbs 7220, 7230 according to an exemplary embodimentof the invention an AAA stent-graft system. A 6-apex version is shown,although more or less apices could be used. This bare stent component7210 has, as shown in FIG. 74, different length hooks 7410, 7420, 7430that, for example, increase in length based upon the distance from thegraft edge (of course, these lengths can decrease in this direction orbe a combination of lengths). In an embodiment, the hooks 7410, 7420,7430 increase in length the further away from the graft edge (i.e., B-1is longer than B-2 and is longer than B-3) because, in an angled neck,hooks further from the graft line are more likely to be further from theaortic wall. Further, shorter hooks nearer to the renal arteries issafer for patients.

FIG. 75 shows an orientation where hooks 7510, 7520, 7530 increase inlength further away from the graft edge and are disposed at staggeredpositions along various circumferential planes at distances from thegraft edge.

FIGS. 73 through 75 and 77 illustrate an eyelet 7700 at each apex at thegraft end (distal) of the bare stent. This feature assists in suturingthe stent to the graft material. Benefits of the eyelet include suturingin an area of the stent with no stresses or strain during normalpost-sewing process steps. Typically, stents are sewn around theintrados of the sinusoid of the stent. This area will be subjected toelastic deformation during post sewing process steps likecrimping/loading and final deployment. Such movements can only havedetrimental effects on the sutures. Additionally, during normalanatomical movements in the body, the intrados of the stent will havethe most movement. An eyelet, as shown in these figures, will not besubject to any movement or plastic deformation that would beyond thegeneral movement of the whole prosthesis. Suturing in the area of astent that will not be subject to any stresses or strain is advantageousfrom a manufacturing perspective. During the sewing process, the needlescan cause small gauges in the stent, which could become focal points forcrack initiation and subsequent fracture. These gauges would be of muchgreater concern in the intrados than in a static area such as the eyelet7700. Should the suprarenal stent of the invention be subjected to afracture after implant, the intrados area of the stent is likely to be aspot where the fracture would occur. If the suture is done in this spot,a fracture could result in the complete disassociation of the suprarenalstent from the graft. By sewing on this added eyelet feature, afractured stent would still have one of the two struts attached to thegraft after that fracture. Thus, once a fracture occurred, it would befar less likely for the second strut in the same area to also break awayfrom the shared intrados. Having the inferior eyelets shown as thesuture securement areas of the stent has significant advantages:

Stents of the invention can be of a size from about 20 mm to about 36mm, and include, for example, 20 mm, 22 mm, 24 mm, 26 mm, 28 mm, 30 mm,33 mm, and 36 mm.

The stent can be cut from a 3 mm OD tube, for example. The width of thecan be equivalent (but not need be equivalent) to the circumference of a3 mm tube. The tubing wall can be, for example, 0.017″. FIGS. 81 to 85illustrate one exemplary embodiment of a laser-cut supra-renal stentwith side hooks according to the invention with exemplary measurementsfor the stent when being manufactured from such a tube. This exemplaryembodiment includes 6 superior and 6 inferior apices, although variantscould have more or less. Strut thickness can be targeted to mimic a wireof approximately 0.016″ to 0.018″ diameter. But can be of varyingdiameters, for example, the wall thickness can be 0.017″.

Barbs can be bent out of plane and sharpened as part of a finishingprocess. All of the barbs, or only a subset of the barbs, may beincluded in the stent of the invention.

The bare stents described above are to be used with the delivery systemsaccording to the invention, which systems include distal apex capturedevices, an example of which is shown in FIG. 69. With the addition ofthe barbs, however, the spaces that previously existed between each ofthe stent arms 8010 (i.e., the lengths between the apices) is now takenup by the barbs. This can be seen, in particular, in FIGS. 80 and 84.Accordingly, the apex capture device previously used is modified to takeaccount of the lost of “space” between the arms 8010.

In an embodiment, the invention is an apex capture device 8600,comprising a proximal apex capture portion 8600 a that includes a nose8601, wherein the nose defines at least one radial restraint, such as apilot holes, represented as 8011, in FIGS. 86C and 88A, that issubstantially parallel to a major axis of the proximal capture portion8600 a and a plurality of tines 8602 extending distally from the nose8601, the tines 8602 are radially distributed about the major axisradial to a most proximal radial restraint and are substantiallyparallel to the major axis; a distal apex capture portion 8610 definingrecesses 8611 distributed radially about the major axis, the recesses8611 mateable with the tines 8602 by relative movement of the proximal8600 a and distal 8610 apex capture portions along the major axis; aplurality of bosses 8612 extending radially from the major axis betweenthe nose 8601 and the distal apex capture portion 8610 and aligned withthe recesses 8611 along the major axis in non-interfering relation withmovement of the tines 8602 into mating relation with the recesses 8611;an elongate member 8614, shown in FIG. 86D, (also known as an innercontrol tube) to which the distal apex capture portion 8610 is fixed,the elongate member 8614 extending through the plurality of bosses 8612and the proximal apex capture portion 8600 a; and a catheter 8613, alsoshown in FIG. 86D, (also referred to as an outer control tube) to whichthe proximal apex capture portion 8600 a is fixed, through which theelongate member extends, whereby movement of the catheter 8613 causesmovement of the proximal apex capture portion 8600 a along the majoraxis between a first position, in which the tines 8602 are mated withthe recesses 8611 and overlie the bosses 8612, and a second position, inwhich the tines 8602 are not mated with the slots and do not overlie thebosses 8612.

“Radial restraint,” as used herein, means restricted movement in adirection normal to the major axis of the delivery system or the apexcapture device, whereby, for example, a barb of a stent could bereleased between tines of the apex capture device.

“Non-interfering relation,” as used herein, means one object is moveablerelative to another object.

The nose 8601 of the apex capture device of the invention can definegrooves 8603 between the tines 8602, wherein the grooves 8603 arealigned with spaces between the bosses 8612.

In an embodiment, the plurality of bosses 8612 of the apex capturedevice of the invention are fixed relative to distal apex captureportion 8610.

The nose, elongate member and each of the tines 8602 of the apex capturedevice of the invention can define a space.

In another embodiment, the invention is a method of releasing a barestent of a stent graft, comprising the steps of moving a catheter, towhich a proximal apex capture portion of an apex capture device isfixed, the proximal apex capture portion defines a radial restraint,along a major axis between a first position, in which tines of theproximal apex capture portion are mated with slots of a distal apexcapture portion and overlie bosses extending radially from a major axisof the apex capture device, and a second position, in which the tinesare not mated with the slots and do not overlie the bosses, therebyreleasing apices of a bare stent from a space defined by the tines, thebosses and the distal apex capture portion.

In an embodiment, the apex capture device employed in the method ofreleasing a bare stent of a stent graft can further include an elongatemember to which the distal apex capture portion is fixed, the elongatemember extending through the proximal apex capture portion and theplurality of bosses.

In another embodiment, the apex capture device employed in the methodsof the invention can further include a catheter to which the proximalapex capture portion is fixed, through which the elongate memberextends, and by which the proximal apex capture portion is moved.

In yet another embodiment, the invention is an apex capture deviceassembly 7600, comprising a proximal apex capture portion 7610 thatincludes a nose 7615, wherein the nose defines at least one radialrestraint, such as a pilot hole, previously described, that issubstantially parallel to a major axis of the proximal capture portionand a plurality of tines, previously described extending distally fromthe nose 7615, as shown, for example, in FIG. 76A, the tines radiallydistributed about the major axis radial to a most proximal radialrestraint and substantially parallel to the major axis; a distal apexcapture portion 7620, as shown, for example, in FIG. 76A, defining slotsdistributed radially about the major axis, the slots mateable with thetimes by relative movement of the proximal and distal apex captureportions along the major axis; a plurality of bosses extending radiallyfrom the major axis between the nose and the distal apex capture portionand aligned with the slots along the major axis in non-interferingrelation with movement of the times into mating relation with the slots;a elongate member to which the distal apex capture portion is fixed, theelongate member extending through the proximal apex capture portion 7610and the plurality of bosses; a catheter to which the proximal apexcapture portion 7610 is fixed, through which the elongate memberextends, whereby movement of the catheter causes movement of theproximal apex portion along the major axis between a first position, inwhich the tines are mated with the slots and overlie the bosses, and asecond position, in which the tines are not mated with the slots and donot overlie the bosses; a bare stent 7630 that includes struts 7631linked by apices, the struts extending between the tines 8602 (FIG.86B), a portion of the apices extending between the bosses and thedistal apex capture portion when the tines are mated to the slots; andat least one suprarenal barb 7632 (FIG. 76B) extending from an eyelet ofthe stent into the radial restraint (not shown).

The stent of the apex capture device assembly of the invention canfurther include at least one bridge between a pair of the struts todefine an eyelet through which a boss extends when a tine is mated to aslot, and wherein the barb extends from the bridge.

In an alternative embodiment, shown in FIG. 76B, the struts 7634 areangled. The struts are angled as a result of clasping the bare stent andrestraining the barbs thereby creating a deeper valley for at least oneinfrarenal barb.

Referring to both FIGS. 76A and 76B, the suprarenal barb of the apexcapture device assembly of the invention is angled (not shown) from amajor plane of the eyelet sufficient to distend the struts to which theeyelet is attached toward the major axis.

The apex capture device of the invention can further include aninfrarenal barb 7635 extending from a distal apex 7636 of the bare stent7630.

The apex capture device assembly of the invention can further include aluminal graft component 7637 fixed to a distal portion of the bare stent7630 and an infrarenal stent 7638 adjacent and distal to the bare stent7630, the infrarenal stent 7638 including struts 7639 linked by proximal7640 and distal 7641 apices, the distal apices 7641 being substantiallyaligned with distal apices 7636 of the bare stent 7630. In anembodiment, the infrarenal stent 7638 of the apex capture deviceassembly 7600 of the invention is fixed within the tubular graftcomponent 7637. Distention of the bare stent struts 7631, 7634consequent to retention of the suprarenal barbs 7632 within the radialrestraint, such as a pilot hole 8011 (FIG. 86C), can cause theinfrarenal barb 7635 of the bare stent 7630 to be recessed betweenstruts 7639 of the infrarenal stent 7638.

For example, as shown in FIGS. 86A, 86B, 86C, 86D and 86E through 88,the proximal apex capture portion 8600 a having the tines 8602 is in thebare stent release position, in which it is separated from the distalapex capture portion 8610 (which is connected to the nose cone 6860(FIG. 88A)). The upstream apices of the stent 8620 (FIG. 87A), whilecaptured and before springing open upon final deployment, are wrappedaround holding bosses 8612 that circumferentially align with arespective one of the tines 8602 and, therefore, extend radially outwardto touch the respective tine 8602, or come close enough to prevent anystent apex release when closed over by the tines 8602. To complete thecapture cavity for the stent apices, the distal apex capture portion8610 has recesses 8611 that are shaped to fit snugly the distal-mostends of each one of the tines 8602. Accordingly, the recesses 8611 ofdistal apex capture portion 8610 are circumferentially offset from thebosses 8612, as represented in FIGS. 86A-86E. Elongate member 8614extends from proximal capture portion 8600 a.

Prior art Z-stents are made of a single length of wire joined at the twoends. Provided herein, and shown in an exemplary embodiment in FIGS. 89and 90, is a multiple-stent 8900 made with a plurality ofcircumferentially adjacent filaments. There are various features thatexist with the multiple-stent 8900 that do not arise in prior artstents.

The multiple-stent 8900 is a wire form stent made from wire that issubstantially smaller in diameter than used in prior art stents/stentgrafts. In spite of this substantial reduction in diameter, the multipleturns around the circumference create a total metal cross-section oneach strut of each stent similar to prior art stents. Having multipleturns in the multiple-stent 8900 creates multiple apices 8910 at eachbend of the multiple-stent 8900. These apices can be used to improveimplantation on an interior wall of a vessel to be treated.Additionally, each of these apices 8910 can be used to catch onto thegraft material of a second modular component, for example, on the graftmaterial of a second part of a bifurcated stent graft that is to bedeployed in the iliac artery opposite the long downstream leg of thebifurcated stent graft. One particular use is that these apices 8910 canbe used to catch onto opposing apices of a stent from the second modularcomponent. The multiple-stent 8900 can be used in any overlap region.Variations of the multiple-stent 8900 can include wire diameter, overallnumber of apices as well as the number of turns (filaments) used.

The multiple-stent 8900 can be made from a single wire circumferentiallyrepeated as shown in FIGS. 89 through 94. The embodiment of FIG. 89stacks the apices 8910 and the embodiment of FIG. 91 encircles theapices 9100. Alternatively, the multiple-stent can be a plurality ofindependent Z-stents intertwined with one another.

To use the multiple-stent to connect two modular components of astent-graft system, the graft and stent are assembled in a non-intuitivemanner to achieve a high modular tensile strength. The graft isassembled such that its longitudinal length is shortened by folding thegraft in on itself in a longitudinal direction. This is done so that thetotal effective graft is substantially unchanged, with respect tointernal diameter. The ability to fold the graft in on itself is done bysewing consecutive leg stents further from one another than wouldnormally be done. FIG. 95 shows a cutaway graft with the surfaces on thebottom representing the portion of the graft that is folded into theupper catheter. Overall, the graft still defines a single lumen. FIG. 96is a close-up of the in-folded area of the graft. Significantly, thisfold 9600 creates a pocket 9610 facing the proximal end of the graft,when in the catheter of the graft. FIG. 97 is a photograph of an exampleof the configuration of FIGS. 95 and 96 applied to both iliac ends of abifurcated stent graft. This particular example shows the fold betweenthe last stent on the right and the stent immediately adjacent the laststent to the left in the figure. If desired, this configuration is seton both legs of the bifurcate as shown in FIG. 97.

These folds 9600 are placed in the areas of the stent graft that willreceive modular components. Accordingly, the folds 9600 are made nearthe distal ends of stent graft components. These folds 9600 can be doneat multiple points along the length, and can also be done at the veryend, or at both locations. To keep the folds 9600 in place, longitudinalstitches are sewn through all the layers of the graft. These stitchesare shown with reference “A” in FIG. 97. If the fold is at the end of asegment, like the stitch shown on the longer leg (top of FIG. 97), therewill be two layers of graft material. If, in comparison, the stitch A isbetween two stents (bottom of FIG. 97), then three layers of graftmaterial will be present. Folding of the graft components is done tocreate pockets on the catheter of the grafts. These pockets are used toreceive the second component of the modular securement mechanism, thestent.

The multiple-stent that is attached to a graft is found at or near theproximal end of the inserting component. The multiple-stent is attachedin a manner that leaves the distally facing apices 9800 unsewn, as shownin FIG. 98. Also shown here is the multiple-stent configuration. Byleaving the distally facing apices unsewn, they can fit into the pockets9610 created by folding the graft of the first component. In addition tousing the unsewn apices of stents to fit into the pockets 9610, anon-stent component can be added to the second component. Anotheralternative may include protruding features on the distal end of thestents. Some exemplary configurations of these features are shown inFIGS. 99 and 100. By having multiple filaments as depicted, it is morelikely that at least some of the filaments' apices will engage withpockets 9610 in the connecting component. The total number of filamentsis not critical, and a monofilament stent could also be sewn in the samemanner.

The configuration shown in FIG. 99 differs from the configuration shownin FIG. 98 by having the sewing performed on a larger percentage of theproximal struts (adjacent the proximal apices). The extra sewingincreases the security of the secure attachment to the stent graft ofthe engaging stent. Further, the distal apices 9900 are flared outwardfrom the wall of the stent graft. The flaring of the distal apices 9900is performed to increase the probability that some or all of the apicescatch into the pockets of the opposing component. Additionally, some,but not all, of the filaments of the multi-filament stent are cut. Thecutting of the filaments also creates additional independent catchpoints for the second component into the opposing first component. Theconcept behind cutting some (but not all) of the filaments is tomaintain some radial force in that segment. The configuration shown inFIG. 100 shows a cutting of all of the distal apices 10000. Thisconfiguration creates a maximum number of catch points for the pockets9610 (or other location). A trade off to this, as mentioned above, isthat there is no radial strength in that area of the stent. Theconfiguration of FIG. 100 only has a single apex cut. If desired, all ormore than one apex could be cut in this matter.

The configuration shown in FIG. 101 modifies the configuration of FIGS.98 to 100 by providing a partially sewn stent 10100 sewn right next to afully sewn stent 10110. Two benefits to this modification immediatelyarise. First, radial strength is increased. This helps keep both stentsagainst the graft material of the first component. Second, theconfiguration helps prevent possible in-folding of the second componentthat could block the lumen of the entire device. This type of in-foldingwould be the result of a poorly supported segment of the secondcomponent being placed under a significant axial load. If the distalapices or other protruding members have caught the pockets of the firstcomponent, then the top (proximal) apices could fold into the lumen.Another way to prevent this potential issue of in-folding due to anaxial load could be to provide a fully supported stent proximal to thestent intended to engage with the first component.

The configuration shown in FIG. 102 illustrates non-stent components10200 used to engage the pockets 9610 (FIG. 96) of the first component.Here, a bio-compatible plastic or polymer is the shape of a closedladder with interior steps, any of the steps can be connected to thestent graft. As shown in FIG. 102, the upstream-most step is connectedto the cranial (upstream) stent at each of the upstream apices. Ofcourse, less than the number of such apices of the component 10200 canbe connected to non-stent component 10200. A desirable shape has thedistal end (downstream) curved outward to capture the pocket 9610 orvessel wall. One benefit of using a non-stent component 10200 is anon-metal reduces wear between adjacent components. These non-stentcomponents 10200 can be put at some or all of the apices of some or allof the stents, or between stents.

Another exemplary embodiment of devices that can be used to connect intothe pocket 9610 (FIG. 96) or the vessel wall is shown in the variationsof FIGS. 103 through 104. The stent 10300 with its downstream capturepegs 10310 can be used in the modular stent securement mechanismsdescribed herein. In this embodiment, the distally facing pegs 10310 ofthe stent are flared out and are not sharpened. With this variation, thedistally facing pegs 10310 are not intended to penetrate through thefabric of the first component in which the pegs 10310 are to beconnected. In such a configuration, the distally facing pegs can end upin a pocket 9610 (FIG. 96) created in the first component.

In still another embodiment, and referring to FIGS. 78A and 78B, theinvention is a stent graft system 7809 comprising a first stent graft7820 that includes a first tubular graft component 7840 a plurality ofoutside stents extending along and fixed to an outside surface of thefirst tubular graft component 7840 and an inside stent 7860 between twooutside stents 7861, 7871, one of which is at a distal end 7880 of thefirst tubular graft component 7840 the inside stent 7860 fixed to aninside surface of the first tubular graft component 7840 and having aplurality of barbs 7863 pointed generally proximally within the firstluminal graft component 7840; and a second stent graft 7873 thatincludes a second tubular graft component 7874 and a plurality ofoutside stents 7875 extending along and fixed to an outside surface ofthe second tubular graft component 7874, whereby insertion of the secondstent graft 7873 into the distal end 7880 of the first tubular graftcomponent 7840 to overlap at least two stents of each of the first 7820and second stent grafts 7873 will cause interfering relation between atleast a portion of the barbs 7863 with a stent of the second tubulargraft component 7874 of the second stent graft 7873. Examples of maximumand minimum overlap of the first and second stent grafts are shown inFIGS. 79A and 79C.

The first tubular graft component 7840 of the stent graft system 7809can be bifurcated and the inside stent 7860 located in one of two legsof the first tubular graft component 7840.

The stent graft system of the invention can further include a pluralityof outside stents 7891 extending along and fixed to an outside surfaceof a second leg 7890 of the bifurcated first luminal graft, and a secondinside stent 7892 between two outside stents, one of which is at adistal end 7893 of the second leg 7890, the second inside stent 7892fixed to an inside surface of the second leg 7890 and having a pluralityof barbs 7894 pointed generally proximally within the second leg 7890.

A third stent graft 7895, shown in FIG. 79A includes a third tubulargraft component 7896 and a plurality of outside stents 7897 extendingalong and fixed to an outside surface of the third tubular graftcomponent 7896, whereby insertion of the third stent graft 7895 into thedistal end 7893 of the second leg 7890 to overlap at least two stents ofeach of the second leg 7890 and third stent graft 7895 will causeinterfering relation between at least a portion of the barbs 7894 with astent or the third tubular graft component 7896 of the third stent graft7895.

Stents of the stent graft system of the invention can be formed, atleast in part, of a superelastic metal, such as nitinol.

The variation shown in FIG. 105A is a stent 10500 with pegs 10510projecting downstream, not from the downstream apices 10520, but fromthe upstream apices 10530. In the variation shown in FIG. 106, the stent10600 has sharpened legs 10610 projecting from the downstream apices10620. Caudally facing barbs can be disposed on any number or all apicesof a leg stent. Sharpened barbs can penetrate the graft material of theprosthesis into which the graft is placed. In many cases, thisconfiguration would be a bifurcate, but could also be a previouslyplaced leg extension.

A further embodiment of the invention is a telescoping stent graftsystem, which is essentially identical to the stent graft system shownin FIGS. 79A and 79C, but lacks at least one set of barbs 7863 and 7894.In this alternative embodiment, the bifurcated first stent graftincludes a bifurcated first tubular graft component, a plurality ofoutside stents extending along and fixed to an outside surface of one oftwo legs of the bifurcated first tubular graft component. Optionally aninside stent extends between two outside stents, one of which is at adistal end of the first tubular graft component, the inside stent fixedto an inside surface of the first tubular graft component. A secondstent graft that includes a second tubular graft component and aplurality of outside stents extending along and fixed to an outsidesurface of the first tubular graft component, whereby the second stentgraft can be inserted into the distal end of a first of two legcomponents of the bifurcated first tubular graft component to overlap atleast two stents of each of the first and second stent grafts; aplurality of stents (e.g., outside stents and/or inside stents)extending along and fixed to an a surface (e.g., outside surface and/orinside surface) of a second leg of the bifurcated first tubular stentgraft. Optionally, a second inside stent is located between two outsidestents, one of which is at a distal end of the second leg, the secondinside stent fixed to an inside surface of the second leg. Also,optionally, a third stent graft is included having a third tubular graftcomponent and a plurality of outside stents extending along and fixed toan outside surface of the third luminal graft component, wherebyinsertion of the third stent graft can be inserted into the distal endof the second leg of the bifurcated first tubular graft component tooverlap at least two stents of each of the first and second stentgrafts. Regardless, the first leg is shorter than the second leg, andthe first leg includes at least one more stent than is required foroverlap of at least two stents of each of the second stent graft.

In an embodiment, one leg of the bifurcated stent graft of the inventioncan shorter in length (i.e., first or short leg) in the other leg (i.e.,second or long leg) of the bifurcated stent graft, as shown in FIGS.78A, 78B, 79A and 79C. When the bifurcated stent graft of the inventionis placed in the abdominal aorta, the long leg of the bifurcated stentgraft can be in the common iliac, as represented, for example, in FIG.72A, or in the aorta.

As shown in FIGS. 78A and 78B, the bifurcated first stent graft of thetelescoping stent graft system of the invention can include at least oneradiopaque marker 7800. In a particular embodiment, the shorter leg ofthe bifurcated first stent graft includes three lateral radiopaquemarkers 7801, 7802, 7803, one of which is at the distal opening of theshort leg, another of which is at the proximal end of the apex of aninside stent (i.e., second stent from the leg opening) and the third ofwhich is at the point of bifurcated on the first stent graft. Theradiopaque marker 7802 located at the apex of the inside stent candelineate the minimum (min) positioning of the third stent graft and theradiopaque marker 7803 can delineate the maximum (max) positioning ofthe third stent graft, as shown in reference to, for example, FIGS. 78A,78B, 127A, 127B, 127C and 127D. Two additional radiopaque markers 7804,7805 are distributed about the distal opening of the short leg.Radiopaque marker 7806 is located at a proximal end of an inside stentin the long leg of the bifurcated first stent graft.

The delivery systems, components of delivery systems, stents, grafts andstent graft systems of the invention can be employed in methods oftreating aortic aneurysms, such as abdominal aortic aneurysms.

In another embodiment, the invention is a method for treating anabdominal aortic aneurysm, comprising steps of directing a sheath anddistal tip of a delivery system to an abdominal aortic aneurysm of apatient through an artery, such as a femoral artery that cansubsequently pass through a common iliac artery, of the patient, thesheath containing a bifurcated stent graft; rotating a lead screw nut ofthe delivery system that is threadably linked to the sheath to therebyretract the sheath at least partially from the bifurcated stent graft;and sliding the lead screw nut along a handle body of the deliverydevice while the lead screw nut is threadably linked to the sheath tothereby further retract the sheath, whereby the bifurcated stent graftis at least partially deployed in the abdominal aortic aneurysm, therebytreating the abdominal aortic aneurysm.

The method of treating an abdominal aortic aneurysm can furtherincluding the step of opening a clasp at a distal end of the deliverydevice to release a bare stent at a proximal end of the bifurcated stentgraft. A portion of a first leg of the bifurcated stent graft can beretained within the sheath when the clasp is opened to release the barestent. The first leg of the bifurcated stent can be retained by fixing astent at a distal end of the first leg between the sheath and a legclasp. The first leg of the bifurcated is the longer of two legs of thebifurcated stent.

In another embodiment, the clasp employed in the method to treat anabdominal aortic aneurysm can distend struts of the proximal stenttoward a major axis of the delivery system when the sheath has beenretracted sufficient to expose the bare stent.

The method to treat an abdominal aortic aneurysm can further include thestep of cannulating a second leg of the bifurcated stent with anextension stent graft while the first leg is being held at leastpartially within the sheath. During cannulation, the leg that is beingheld is longer than the leg that is being cannulated and, optionally,the cannulated leg is in telescoping relation with the extension stentgraft. The cannulated leg can overlap the extension stent graft by atleast two stents of each of the cannulated leg and the extension stentgraft. The cannulated leg can include at least one more stent than isrequired to overlap the extension leg by two stents of each of thecannulated leg and the extension stent graft. A stent second from thedistal end of the cannulated leg can be within the graft of thebifurcated stent graft. The stent second from the distal end of thebifurcated graft can include barbs that extend inwardly and proximallyfrom the stent.

In another embodiment, the method of treating an abdominal aorticaneurysm can further include the steps of releasing the bifurcated stentgraft from the leg clasp, and then detaching a slider and the sheathfrom the remainder of the delivery device and withdrawing the remainderof the device from the patient while leaving the slider and sheathsubstantially in place and, optionally, further including the step ofdelivering a second extension through sheath and to the first leg andcannulating the first leg with the second extension. The cannulatedsecond leg can overlap the extension stent graft by at least two stentsof each of the cannulated first leg and the second extension. Thecannulated first leg can include at least one more stent than isrequired to overlap the extension leg by two stents of each of thecannulated first leg and the second extension. A stent second from thedistal end of the cannulated first leg can be within the graft of thebifurcated stent graft. The stent second from the distal end of thebifurcated graft includes barbs that can extend inwardly and proximallyfrom the stent.

The methods of the invention have an advantage of repositioning of agraft (e.g., bifurcated graft, second stent graft, third stent graft)if, for example, a clinician determines initial positioning of the graftis less than optimal. The graft can be repositioned at its proximal anddistal end and proximally and distally in an aorta or branch of anaorta, such as a common iliac artery.

FIGS. 105A, 105B and 105C represent embodiments of a stent and use ofstent in a telescoping stent graft system of the invention.

FIGS. 107 to 109 illustrate various configurations for incorporatinghooks or barbs to Z-stents, in particular, bare stents, without usingthe material of the stent itself. FIG. 107 illustrates an exemplaryembodiment of a crimp hook 10700 according to the invention. A hook10710 is attached to or integral with a crimp sleeve 10720 that is tobecome part of a bare stent 10800 (bare spring) on an endoluminal stentgraft prosthesis. Many Z-stents are already connected at the two ends bya crimp sleeve to complete the circumference. The configuration addsactive fixation of the stent graft assembly, once deployed, into thesurrounding tissue of the vessel to prevent migration of the prosthesispost-deployment. To create the crimp hook 10700, for example, the hook10710 (which can be a pointed or sharpened wire if desired) can bewelded onto the body of the crimp sleeve 10720. The crimp hook 10700 is,then, attached to the ends of the bare stent 10800 by crimping (orwelding) it to the strut 10810. If multiple crimp hooks 10700 aredesired, the crimp hooks 10700 can be connected to individual stentportions 10820 defined by one apex 10830 and two halves of struts 10840,for example.

Alternative to the exemplary tubular structure shown in FIG. 107, thecrimp sleeve 10720 can be a clamshell that is placed over two adjacenthalves of a strut 10840 (or just a single, unbroken strut 10840) andcrimped thereon. After the bare stent 10800 is equipped with the crimphooks 10700, it can be affixed to the end of the stent graft 10900 asshown in FIG. 109. The crimp hooks 10700 in FIG. 109 are shown asrotated around the respective struts 10840 of the bare stent 10800 sothat they can be seen in the figure of this drawing. In use, however,the hooks 10710 will, for best apposition with the vessel wall, bepointed substantially radially outward from the longitudinal centralaxis of the stent graft.

In contrast to the bare stent crimp hooks above, FIGS. 110 and 111illustrate a crimp hook 11000 that is attached/affixed to the edge ofthe main body of the graft 11200, as shown in FIGS. 112 and 113. Withthe configuration shown, the crimp hook 11000 slides over the edge ofthe graft material 11100 (illustrated with a dashed line) and iscompressed so that the two edges 11110, 11120 of the crimp pinch thegraft material 11100 therebetween to create a mechanical lock onto thegraft material 11100. This configuration adds active fixation of thestent graft assembly, once deployed, into the surrounding tissue of thevessel to prevent migration of the prosthesis post-deployment. Likeabove, the crimp hook 11000 can be welded to the crimp body 11020, forexample, or can be integral therewith.

It is noted that providing barbs or hooks on the bare stent of the stentgraft (tube or bifurcated) increases the possibility of disadvantageouspuncture or scraping, whether to the outer sheath or to the interior ofthe vessel wall. In particular, with regard to the stent embodiments ofFIGS. 73 to 76, 79 to 85, and 103 to 106, for example, it would bedesirable to entirely prevent the possibility of inadvertent damage toeither the outer sheath or the vessel wall. To prevent such damage fromoccurring, the delivery system according to the invention employing barestents having such barbs is provided with a material umbrella 11400.

In one exemplary embodiment illustrated in FIG. 114, the umbrella 11400is attached (slideably or fixedly) to the catheter 11410 controlling theproximal apex capture portion 11420. When the stent graft 11500 iscollapsed and loaded within the outer sheath 11510, and is capturedwithin the proximal apex capture device 11420, 11520 (as shown in FIG.115), the bare stent 11530 spans the distance between the leading edgeof the graft and the apex capture device 11420, 11520. The umbrella11400 can be disposed outside the stent graft (and inside the outersheath 11510) but, in the exemplary embodiment shown in FIGS. 114 and115, the umbrella 11400 is held by the catheter 11410 interior to boththe umbrella 11400 and the outer sheath 11510. Arms 11402 of theumbrella 11400 extend therefrom between respective apices of the barestent 11530. The arms 11402 are relatively narrow at the intermediateportion where each is passing through the apices and expand to berelatively wide at their distal ends. In such a configuration, thedistal ends of each arm 11402 can spread out over the adjacent barestent apices and, if wide enough, overlap with adjacent other arms 11402to canopy out around the entire circumference of the exposed bare stent11530 as shown in FIG. 115. At least one passage 11404 is formed at thedistal portion of the arm 11402 so that a respective tine of theproximal apex capture portion 11420 can extend therethrough. In thisconfiguration, the wide distal portions of the arms 11402 are controlledand stay against the bare stent, protecting the outer sheath 11510 andinterior vessel wall up until the time when the apex capture device11420, 11520 is actuated (a position that is shown in FIG. 115 but thebare stent 11530 and the arms 11402 have not yet been released from thetines of the proximal apex capture portion 11420). FIG. 116 isphotograph depicting how the umbrella 11400 protects the interior of thevessel wall 11600 before the delivery system has retracted the innercatheter 11410. As the inner catheter 11410 is retracted, the umbrella11400 will slide out from between the bare stent 11530 and the vesselwall 11600.

In an exemplary embodiment where infra-renal barbs of the stent graftare not desired, they can be moved higher on the bare stent so that theycan be covered by the fabric strips of the umbrella 11400.

FIGS. 117 to 124 illustrate a concept according to the invention thatuses a proximal clasp to expand the taper tip and create/improve a sealbetween the nose cone/tip and the outer sheath, the interfaceeliminating pronouncement of the outer sheath edge by taking up thespace between the tip and the outer sheath. The delivery systemsdescribed herein (e.g., AAA delivery systems), the concept of removingthe inner components of the delivery system (tip/support member) whileleaving the outer sheath behind requires the tip to be smaller than theID of the outer sheath. Due to the smaller shape of the tip, the problemof “fish mouthing” can occur at the tip-sheath interface. “Fishmouthing” occurs when the edge of the sheath becomes pronounced when thetip sheath interface is navigating the vessel, which could potentiallyscore the vessel wall, see FIGS. 117 and 118. To solve the problem thespace between the tip and the sheath needs to be eliminated but stillallow for removal of the tip. See FIGS. 119 to 120. To accomplish thisremoval of material underneath the distal claps and allowing theproximal clasp to be moved more forward so that the taper tip can beexpanded over the clasp taking lip the space between the sheath and tip.

FIGS. 125 and 126 illustrate an exemplary embodiment of a passiveproximal retainer device 12500 for the AAA bifurcated stent graftaccording to the invention, which retainer device 12500 is referred toherein as a spoked hub. A proximal retainer is required for theipsilateral leg of the AAA bifurcated stent graft. The proximal fixationholds the stent graft in the deployment sheath during cannulation of thecontralateral leg with the guidewire and the leg stent. The passiveproximal retainer device 12500 is a hub fitted to the support member atthe proximal end of the stent graft. The passive proximal retainerdevice 12500 has spokes 12502 radiating out from a central hub 12504.The number of spokes is equivalent to the number of struts on theproximal end of the stent. The spokes are engaged and trapped by theindividual struts of the stent during the loading process. The stentgraft is loaded into the deployment sheath through the use of a funnel.When the proximal end of the stent is just about in the deploymentsheath, the support member is loaded next to the graft and the spokes ofthe hub are engaged in the graft struts. The graft and support memberare, then, pulled into the sheath. During deployment of the stent, thegraft will not be released from the sheath until the sheath is fullyretracted over the spoked hub. The outer diameter (OD) of the spokes areabout 0.008 inches less than the inner diameter (ID) of the sheath,therefore, the stent struts are trapped by the spoked hub until thesheath is retracted.

The teachings of all patents, published applications and referencescited herein are incorporated by reference in their entirety. Theteaching of U.S. patent application Ser. Nos. 10/884,136; 10/784,462;11/348,176; 11/699,701; 11/699,700; 11/700,609; 11/449,337; 11/353,927;11/701,867; 11/449,337; 11/700,510; 11/701,876; 11/828,653; 11/828,675;and 12/137,592 are also incorporated by reference herein in theirentirety.

While this invention has been particularly shown and described withreferences to example embodiments thereof, it will be understood bythose skilled in the art that various changes in form and details may bemade therein without departing from the scope of the inventionencompassed by the appended claims.

1. A method of releasing a bare stent of a stent graft, comprising thesteps of moving a control lumen, to which a proximal apex captureportion of an apex capture device is fixed, the proximal apex captureportion defining pilot holes extending along a major axis of the lumen,from a first position, in which tines of the proximal apex captureportion are mated with a distal apex capture portion, and in which barbsextending distally from proximal apices of a bare stent of a stent graftare radially restrained by the pilot holes, and a second position, inwhich the tines are not mated with the distal apex capture portion,thereby releasing apices of a bare stent from a space defined at leastin part by the tines and the distal apex capture portion, and releasingthe barbs from radial restraint by the pilot holes.
 2. The method ofclaim 1, wherein the distal apex capture portion defines slots that matewith the tines of the proximal apex capture portion when the controllumen is in the first position.
 3. The method of claim 2, wherein theelongate member extends through the lumen.
 4. The method of claim 1,wherein the barbs each extend distally from a proximal apex of the barestent.
 5. The method of claim 4, wherein the barbs are radiallyrestrained by the pilot holes where the barbs extend from a bridgecomponent of each respective proximal apex of the bare stent.
 6. Themethod of claim 1, wherein the tines overlie bosses extending radiallyfrom the major axis of the distal capture portion, whereby the spacefrom which the distal apices are released is defined by the tines, thebosses, and the distal apex capture portion.
 7. A system for releasing abare stent of a stent graft, comprising: a) a guidewire lumen having aproximal end and a distal end; b) a nose cone fixed to the distal end ofthe guidewire lumen, the nose cone having a proximal end and a distalend; c) a control lumen having a proximal end, a distal end, and a majoraxis, the control lumen extending circumferentially about the guidewirelumen and longitudinally moveable along the guidewire lumen; and d) anapex capture device, including i) a distal apex capture portion fixed tothe guidewire lumen at the proximal end of the nose cone, and ii) aproximal apex capture portion fixed to the distal end of the controllumen, the proximal apex capture portion defining pilot holes anddefining tines that extend distally from the remainder of the proximalapex capture portion and mate with distal capture portion when thecontrol lumen is in a first position, and disengage from the distalcapture portion when the control lumen is moved proximally along theguidewire lumen from the first position to a second position.